TRI-LUMA®
(fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Cream
For External Use Only
Not for Ophthalmic Use
TRI-LUMA® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) contains fluocinolone acetonide, USP, hydroquinone, USP, and tretinoin, USP, in a hydrophilic cream base for topical application.
Fluocinolone acetonide is a synthetic fluorinated corticosteroid for topical dermatological use and is classified therapeutically as an anti-inflammatory. It is a white crystalline powder that is odorless and stable in light.
The chemical name for fluocinolone acetonide is: (6 ,11 ,16 )-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-pregna-1,-4-diene-3,20-dione.
The molecular formula is C24H30F2O6 and molecular weight is 452.50. Fluocinolone acetonide has the following structural formula:
 |
Hydroquinone is classified therapeutically as a depigmenting agent. It is prepared from the reduction of p-benzoquinone with sodium bisulfite. It occurs as fine white needles that darken on exposure to air.
The chemical name for hydroquinone is: 1,4-benzenediol.
The molecular formula is C6H6O2 and molecular weight is 110.11.
Hydroquinone has the following structural formula:
 |
Tretinoin is all-trans-retinoic acid formed from the oxidation of the aldehyde group of retinene to a carboxyl group. It occurs as yellow to light-orange crystals or crystalline powder with a characteristic odor of ensilage. It is highly reactive to light and moisture. Tretinoin is classified therapeutically as a keratolytic.
The chemical name for tretinoin is: (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid.
The molecular formula is C20H28O2 and molecular weight is 300.44.
Tretinoin has the following structural formula:
 |
Each gram of TRI-LUMA® Cream contains Active: fluocinolone acetonide 0.01% (0.1 mg), hydroquinone 4% (40 mg), and tretinoin 0.05% (0.5 mg). Inactive: butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol.
Last updated on RxList: 10/10/2008
TRI-LUMA® Cream is indicated for the short-term intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens.
The following are important statements relating to the indication and usage of TRI-LUMA® Cream:
TRI-LUMA® Cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime.
Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma including about 1/2 inch of normal appearing skin surrounding each lesion. Rub lightly and uniformly into the skin. Do not use occlusive dressing.
During the day, use a sunscreen of SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day.
Therapeutic effects may be observed as early as 4 weeks. Use TRI-LUMA® Cream daily for as long as the melasma lesions persist. Treatment should be discontinued when melasma is resolved. When melasma recurs, retreat with TRI-LUMA® Cream until the condition clears.
TRI-LUMA® Cream is supplied in 30 g aluminum tubes, NDC 0299-5950-30.
Keep tightly closed. Store at controlled room temperature 68° to 77°F (20°-25°C). Protect from freezing.
Marketed by: GALDERMA LABORATORIES, L.P., Fort Worth, TX 76177, USA. www.triluma.com. Manufactured by: Hill Laboratories, Inc., Sanford, FL 32773 USA. Revised: December 2003. FDA rev date: 1/18/2002
Last updated on RxList: 10/10/2008
In the controlled clinical trials, adverse events were monitored in the 161 patients who used TRI-LUMA® Cream once daily during an 8-week treatment period. There were 102 (63%) patients who experienced at least one treatment-related adverse event during these studies. In the long-term clinical study, from a total of 314 patients treated with TRI-LUMA® Cream for at least 180 cumulative days, there were 202 (64%) patients who experienced at least one treatment-related adverse event. No significant increase in severity or incidence of the adverse events was observed from long term use of TRI-LUMA® Cream compared with events reported during the 8-week controlled clinical studies. The most frequently reported adverse events that were observed from the controlled clinical trials and the long term safety were erythe-ma, desquamation, and burning, at the site of application. The number and percentages of these events were markedly lower in the long-term study than in the controlled clinical studies. The great majority of these events were mild to moderate in severity.
Adverse events reported by at least 1% of patients and judged by the investigators to be reasonably related to treatment with TRI-LUMA® Cream from the controlled clinical studies and the long-term study are summarized (in decreasing order of frequency).
Incidence and Frequency of Treatment-related Adverse Events
with TRI-LUMA® Cream in at least 1% or more of Patients (N=161)
| Adverse Event | Number (%) of Patient |
| Erythema | 66 (41%) |
| Desquamation | 61 (38%) |
| Burning | 29 (18%) |
| Dryness | 23 (14%) |
| Pruritus | 18 (11%) |
| Acne | 8 (5%) |
| Paresthesia | 5 (3%) |
| Telangiectasia | 5 (3%) |
| Hyperesthesia | 3 (2%) |
| Pigmentary changes | 3 (2%) |
| Irritation | 3 (2%) |
| Papules | 2 (1%) |
| Acne-like rash | 1 (1%) |
| Rosacea | 1 (1%) |
| Dry mouth | 1 (1%) |
| Rash | 1 (1%) |
| Vesicles | 1 (1%) |
In an open-label long-term safety study, patients who have had cumulative treatment of melasma with TRI-LUMA® Cream for 6 months showed a similar pattern of adverse events as in the 8-week studies.
Summary of Most Common Treatment-Related Adverse Events
(TRAE)a Study 29
| Preferred Term | Number (%) of Patients | |
| Treatment Group | ||
| TRI-LUMA® | ||
| All Patients (N=569) |
Patients with at least 180 Cumulative Days
of TRI-LUMA® Treatment Days (N=314) |
|
| Total number of TRAEa | 326 (57.29) | 202 (64.33) |
| Application site erythema | 166 (29.17) | 105 (33.44) |
| Application site desquamation | 145 (25.48) | 91 (28.98) |
| Application site dryness | 46 (8.08) | 27 (8.60) |
| Application site burning | 38 (6.68) | 25 (7.96) |
| Application site inflammation | 31 (5.45) | 24 (7.64) |
| Application site reaction nos | 31 (5.45 | 17 (5.41) |
| Application site rash | 30 (5.27) | 18 (5.73) |
| Application site pruritus | 24 (4.22) | 18 (5.73) |
| Application site pigmentation changes | 23 (4.04) | 18 (5.73) |
| a Defined as “probably”
or “possibly” related to study medication Data source: Section 14.3, Tables 8.1.1, 8.1.2, and 8.1.3 |
||
The severity, incidence and type of adverse events experienced from 6 months cumulative use were not significantly different from the events reported for all patients.
The incidence of application site pigmentation changes that occurred in both the controlled and long-term safety studies included 11 occurrences of hypopigmentation and 18 occurrences of hyperpigmentation in 27 patients.
The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.
TRI-LUMA® Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, whose occurrence should prompt discontinuation of therapy.
Cutaneous hypersensitivity to the active ingredients of TRI-LUMA® Cream has been reported in the literature. In a patch test study to determine sensitization potential in 221 healthy volunteers, three volunteers developed sensitivity reactions to TRI-LUMA® Cream or its components.
Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentration of alcohol and astringent, and other irritants or keratolytic drugs while on TRI-LUMA® Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Last updated on RxList: 10/10/2008
TRI-LUMA® Cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
TRI-LUMA® Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, whose occurrence should prompt discontinuation of therapy. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.
Cutaneous hypersensitivity to the active ingredients of TRI-LUMA® Cream has been reported in the literature. In a patch test study to determine sensitization potential in 221 healthy volunteers, three volunteers developed sensitivity reactions to TRI-LUMA® Cream or its components.
TRI-LUMA® Cream contains hydroquinone and tretinoin that may cause mild to moderate irritation. Local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation does not preclude treatment. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued.
TRI-LUMA® Cream also contains the corticosteroid fluocinolone acetonide. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced by systemic absorption of topical corticos-teroid while on treatment. If HPA axis suppression is noted, the use of TRI-LUMA® Cream should be discontinued. Recovery of HPA axis function generally occurs upon discontinuation of topical corticosteroids.
Exposure to sunlight, sunlamp, or ultraviolet light should be avoided. Patients who are consistently exposed to sunlight or skin irritants either through their work environment or habits should exercise particular caution. Sunscreen and protective covering (such as the use of a hat) over the treated areas should be used. Sunscreen use is an essential aspect of melasma therapy, as even minimal sunlight sustains melanocytic activity.
Weather extremes, such as heat or cold, may be irritating to patients treated with TRI-LUMA® Cream. Because of the drying effect of this medication, a moisturizer may be applied to the face in the morning after washing.
Application of TRI-LUMA® Cream should be kept away from the eyes, nose, or angles of the mouth, because the mucosa is much more sensitive than the skin to the irritant effect. If local irritation persists or becomes severe, application of the medication should be discontinued, and the health care provider consulted. Allergic contact dermatitis, blistering, crusting, and severe burning or swelling of the skin and irritation of the mucous membranes of the eyes, nose, and mouth require medical attention.
If the medication is applied excessively, marked redness, peeling, or discomfort may occur.
This medication is to be used as directed by the health care provider and should not be used for any disorder other than that for which it is prescribed.
The following tests may be helpful in evaluating patients for HPA axis suppression:
ACTH or cosyntropin stimulation test
A.M. plasma cortisol test
Urinary free cortisol test
Long-term animal studies to determine the carcinogenic potential of TRI-LUMA® Cream have not been conducted.
Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown.
Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect has been confirmed in a later study in pigmented mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significance of these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.
Mutagenicity studies were not conducted with this combination of active ingredients. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Treatment with hydroquinone has resulted in positive findings for genetic toxicity in the Ames assay in bacterial strains sensitive to oxidizing mutagens, in in vitro studies in mammalian cells, and in the in vivo mouse micronucleus assay. Tretinoin has been shown to be negative for mutagenesis in the Ames assay. Additional information regarding the genetic toxicity potential of tretinoin and of fluo-cinolone acetonide is not available.
A dermal reproductive fertility study was conducted in SD rats using a 10-fold dilution of the clinical formulation. No effect was seen on the traditional parameters used to assess fertility, although prolongation of estrus was observed in some females, and there was a trend towards an increase in pre-and post-implantation loss that was not statistically significant. No adequate study of fertility and early embryonic toxicity of the full-strength drug product has been performed. In a six-month study in minipigs, small testes and severe hypospermia were found when males were treated topically with the full strength drug product.
TRI-LUMA® Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. It is difficult to interpret the animal studies on terato-genicity with TRI-LUMA® Cream, because the availability of the dermal applications in these studies cannot be assured, and comparison with clinical dosing is not possible. There are no adequate and well-controlled studies in pregnant women. TRI-LUMA® Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
TRI-LUMA® Cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. However, human data have not confirmed an increased risk of these developmental abnormalities when tretinoin is administered by the topical route.
In clinical trials involving TRI-LUMA® Cream in the treatment of facial melasma, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy. Thus, safety and efficacy of TRI-LUMA® Cream in pregnancy has not been established. In general, use of drugs should be reduced to a minimum in pregnancy. If a patient has been inadvertently exposed to TRI-LUMA® Cream in pregnancy, she should be counseled on the risk of teratogenesis due to this exposure. The risk of teratogene-sis due to topical exposure to TRI-LUMA® Cream may be considered low. However, exposure during the period of organogenesis in the first trimester is theoretically more likely to produce adverse outcome than in later pregnancy.
Data Discussion: Tretinoin is considered to be highly teratogenic upon systemic administration. Animal reproductive studies are not available with topical hydroquinone. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
1. Human Data.
2. Animal Data.
All pregnancies have a risk of birth defect, loss, or other adverse event regardless of drug exposure. Typically, estimates of increased fetal risk from drug exposure rely heavily on animal data. However, animal studies do not always predict effects in humans. Even if human data are available, such data may not be sufficient to determine whether there is an increased risk to the fetus. Drug effects on behavior, cognitive function, and fertility in the offspring are particularly difficult to assess.
Corticosteroids, when systemically administered, appear in human milk. It is not known whether topical application of TRI-LUMA® Cream could result in sufficient systemic absorption to produce detectable quantities of fluocinolone acetonide, hydroquinone, or tretinoin in human milk. Because many drugs are secreted in human milk, caution should be exercised when TRI-LUMA® Cream is administered to a nursing woman. Care should be taken to avoid contact between the infant being nursed and TRI-LUMA® Cream.
Safety and effectiveness of TRI-LUMA® Cream in pediatric patients have not been established.
Clinical studies of TRI-LUMA® Cream did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Last updated on RxList: 10/10/2008
TRI-LUMA® Cream is contraindicated in individuals with a history of hypersensitivity, allergy, or intolerance to this product or any of its components.
Last updated on RxList: 10/10/2008
One of the components in TRI-LUMA® Cream, hydroquinone, is a depigmenting agent, and may interrupt one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. However, the mechanism of action of the active ingredients in TRI-LUMA® Cream in the treatment of melasma is unknown.
Percutaneous absorption of unchanged tretinoin, hydroquinone and fluocinolone acetonide into the systemic circulation of two groups of healthy volunteers (Total n=59) was found to be minimal following 8 weeks of daily application of 1g (Group I, n=45) or 6g (Group II, n=14) of TRI-LUMA® Cream.
For tretinoin quantifiable plasma concentrations were obtained in 57.78% (26 out of 45) of Group I and 57.14% (8 out of 14) of Group II subjects. The exposure to tretinoin as reflected by the Cmax values ranged from 2.01 to 5.34 ng/mL (Group I) and 2.0 to 4.99 ng/mL (Group II). Thus, daily application of TRI-LUMA® Cream resulted in a minimal increase of normal endogenous levels of tretinoin. The circulating tretinoin levels represent only a portion of total tretinoin-associated retinoids, which would include metabolites of tretinoin and that sequestered into peripheral tissues.
For hydroquinone quantifiable plasma concentrations were obtained in 18% (8 out of 44) Group I subjects. The exposure to hydroquinone as reflected by the Cmax values ranged from 25.55 to 86.52 ng/mL. All Group II subjects (6g dose) had post-dose plasma hydroquinone concentrations below the quantitation limit. For fluocinolone acetonide, Groups I and II subjects had all post-dose plasma concentrations below quan-titation limit.
Two adequate and well-controlled efficacy and safety studies were conducted in 641 patients between the ages of 21 to 75 years, having skin phototypes I-IV and moderate to severe melasma of the face. TRI-LUMA® Cream was compared with 3 possible combinations of 2 of the 3 active ingredients [(1) hydroquinone 4% (HQ) + tretinoin 0.05% (RA); (2) fluocinolone acetonide 0.01% (FA) + tretinoin 0.05% (RA); (3) fluocinolone acetonide 0.01% (FA) + hydroquinone 4% (HQ)], contained in the same vehicle as TRI-LUMA® Cream. Patients were instructed to apply their study medication each night, after washing their face with a mild soapless cleanser, for 8 weeks. Instructions were given to apply a thin layer of study medication to the hyperpigmented lesion, making sure to cover the entire lesion including the outside borders extending to the normal pigmented skin. Patients were provided a mild moisturizer for use as needed. A sunscreen with SPF 30 was also provided with instructions for daily use. Protective clothing and avoidance of sunlight exposure to the face was recommended.
Patients were evaluated for melasma severity at Baseline and at Weeks 1, 2, 4, and 8 of treatment. Primary efficacy was based on the proportion of patients who had an investigators' assessment of treatment success, defined as the clearing of melasma at the end of the eight-week treatment period. The majority of patients enrolled in the two studies were white (approximately 66%) and female (approximately 98%). TRI-LUMA® Cream was demonstrated to be significantly more effective than any of the other combinations of the active ingredients.
PRIMARY EFFICACY ANALYSIS:
Investigators' Assessment of Treatment Success* At the End
of 8 Weeks of Treatment
| TRI-LUMA® | HQ+RA | FA+RA | FA+HQ | ||
| Study No. 1 | Number of Patients | 85 | 83 | 85 | 85 |
| No. of Successes | 32 | 12 | 0 | 3 | |
| Proportion of Successes | 38% | 15% | 0 | 4% | |
| p-value | <0.001 | <0.001 | <0.001 | ||
| Study No. 2 | Number of Patients | 76 | 75 | 76 | 76 |
| No. of Successes | 10 | 3 | 3 | 1 | |
| Proportion of Successes | 13% | 4% | 4% | 1% | |
| p-value | 0.045 | 0.042 | 0.005 | ||
| *Treatment success was defined
as melasma severity score of zero (melasma lesions cleared of hyperpigmentation).
p-value is from Cochran-Mantel-Haenszel chi-square statistics controlling for pooled investigator and comparing TRI-LUMA® Cream to the other treatment groups. |
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In the Investigators' assessment of melasma severity at Day 56 of treatment, the following table shows the clinical improvement profile for all patients treated with TRI-LUMA® Cream based on severity of their melasma at the start of treatment.
Investigators' Assessment of Change in Melasma Severity
from Baseline to Day 56 of Treatment (combined results from studies 1 and 2)
| Number (%) of Patients at Day 56a | |||||||
| Baseline | Clearedb | Mildb | Moderateb | Severeb | Missingb | ||
| Severity Rating | N | N (%) | N (%) | N (%) | N (%) | N (%) | |
| TRI-LUMA® | Moderate | 124 | 36 (29) | 63 (51) | 18 (15) | 0 (0) | 7 (6%) |
| Cream N=161 | Severe | 37 | 6 (16) | 19 (51) | 9 (24) | 2 (5) | 1 (3%) |
| a Assessment based on patients
with severity scores at Day 56. Percentages are based on the total number
in the treatment group population. b Does not include patients who cleared before Day 56 or were missing from the Day 56 assessment. |
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Assessment Scale: Cleared (melasma lesions approximately equivalent to surrounding normal skin or with minimal residual hyperpigmentation); Mild (slightly darker than the surrounding normal skin); Moderate (moderately darker than the surrounding normal skin); Severe (markedly darker than the surrounding normal skin).
Patients experienced improvement of their melasma with the use of TRI-LUMA® Cream as early as 4 weeks. Among the 7 patients that cleared at the end of 4 weeks of treatment with TRI-LUMA® Cream at which time treatment was stopped, 3 patients maintained remission while 4 patients had relapse at the final 8th week evaluation point.
After 8 weeks of treatment with the study drug, patients entered into an open-label long-term safety study in which TRI-LUMA® CREAM was given on an as-needed basis for the treatment of melasma. The objective was to provide evidence of local and systemic safety with cumulative use of TRI-LUMA® Cream for longer than 6 months, up to one year. Patients were instructed to apply TRI-LUMA® Cream once daily at nighttime after washing their face with a mild soapless cleanser, also provided a mild moisturizer for use as needed and a sunscreen with SPF 30 for daily use, in combination with the use of protective clothing and avoidance of sunlight exposure to the face. Patients were treated daily until melasma is resolved, and then retreated when melasma recurred. The majority of patients used TRI-LUMA® for no more than two courses of treatment and these patients experienced longer remissions. Both the duration of treatment and interval of time between treatment courses decreased with increasing number of treatment courses. Additionally, 24 patients (approximately 8%) cleared of melasma without re-occurrence, for a period of one year.
Last updated on RxList: 10/10/2008
TRI-LUMA®
(fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) Cream
Read this information carefully before you begin treatment. Read the information you get whenever you get more medicine. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about TRI-LUMA® (try-LOOM-ah), ask your doctor. Only your doctor can determine if TRI-LUMA® is right for you.
What is the most important information I should know about TRI-LUMA® Cream?
Use of TRI-LUMA® Cream in pregnant women may carry the chance of having birth defects in the baby. Tell your doctor if you are pregnant, may be pregnant, or plan to become pregnant. Your doctor will talk with you about the benefits and risks of using TRI-LUMA® during pregnancy to help decide if the benefits for you are greater than the risks. You may decide to delay treatment until after your baby is born.
If you become pregnant while taking TRI-LUMA® Cream, tell your doctor right away. You should discuss the chances that your baby may be harmed. Using TRI-LUMA® Cream early in pregnancy may be more likely to produce birth defects than using it later in pregnancy.
What is TRI-LUMA® Cream?
TRI-LUMA® (try-LOOM-ah) Cream is a medicine with three active components. You put TRI-LUMA® Cream on your face to treat a skin condition called melasma. Melasma consists of dark (hyperpigment-ed) spots on facial skin, especially on the cheeks and forehead. This condition usually happens with hormone changes.
TRI-LUMA® Cream is for short-term and intermittent long-term treatment of moderate to severe melas-ma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. TRI-LUMA® Cream showed a significantly favorable safety profile for the long-term treatment of melas-ma, up to 6 months. Milder forms of melasma may not need treatment with medicine. Melasma can also be managed by staying out of the sun or by stopping the use of birth control methods that involve hormones.
In clinical studies, after 8 weeks of treatment with TRI-LUMA® Cream, most patients had improvements, with 42 (26%) out of 161 patients experiencing complete clearing of their melasma. In most patients treated with TRI-LUMA® Cream, melasma came back after treatment was stopped. If the underlying causes of melasma, such as the use of certain birth control pills or too much exposure to sunlight, are not removed, melasma will come back when you stop treatment. In the long-term studies, patients were treated with TRI-LUMA® Cream on and off, whenever their melasma comes back until it clears. About 300 patients used TRI-LUMA® Cream intermittently (not continuously) for 180 days, and majority of the side effects were mild in severity. TRI-LUMA® Cream may improve your melasma, but it is NOT a cure.
Who should not use TRI-LUMA® Cream?
Do not use TRI-LUMA® if you are allergic to the medicine or any of its ingredients. See the end of this leaflet for a list of ingredients.
What should I tell my doctor before taking TRI-LUMA® ?
If you are pregnant, think you are pregnant, plan to be pregnant or are nursing an infant, tell your doctor. Your doctor will decide with you whether the benefits in using TRI-LUMA® Cream will be greater than the risks. If possible, delay treatment with TRI-LUMA® Cream until after the baby is born.
Tell your doctor about all the other medicines and skin products you use, including prescription and nonprescription medicines, cosmetics, and supplements. They may make your skin more sensitive to sunlight.
How should I use TRI-LUMA® Cream?
TRI-LUMA® Cream should be used as instructed by your doctor.
To help you use the medicine correctly, follow these steps:
Use a sunscreen of at least SPF 30 and a wide-brimmed hat over the treated areas. It requires only a small amount of sunlight to worsen melasma. Melasma can get worse even if you don't get sunburn.
Only your doctor knows which other medicines may be helpful during treatment, and will tell you about them if needed. Do not use other medicines unless your doctor approves them.
If you get sunburned, stop using TRI-LUMA® Cream until your skin is healed.
After stopping TRI-LUMA® treatment, continue to protect your skin from sunlight.
What should I avoid while using TRI-LUMA® Cream?
Sunlight or ultraviolet light. Too much natural sunlight or artificial sunlight from a sunlamp can cause sunburn. Dark skin patches may become darker when the skin is exposed to sunlight. You don't have to have a sunburn to make your melasma worse.
TRI-LUMA® can make your skin more likely to get sunburn or develop other unwanted effects from the sun. Protect your skin from natural sunlight as much as possible to help prevent further darkening of existing dark patches and formation of new ones. Staying out of the sun is especially important for women who take birth control pills or hormone replacement therapy, and for people who have had dark patches in the past.
Use an effective sunscreen any time you are outside, even on hazy days. The sunscreen should have SPF (sun protection factor) of 30 or more. Use sunscreen year-round on areas of the skin that are regularly exposed to sunlight, such as your face and hands. If possible, protect the treated area from sunlight exposure.
If you spend a lot of time outside, be especially careful of sunlight. Ask your doctor what SPF level will give you the needed high level of protection. If you will be outside, wear protective clothing, including a hat.
Do not use sunlamps while you use TRI-LUMA® Cream.
Heat, wind and cold. Heat and cold tend to dry or irritate normal skin. Skin treated with TRI-LUMA® Cream may be more likely to react to heat and cold. Your doctor can recommend ways to manage your melasma under these conditions.
Other skin products and medicines. Avoid products that may dry or irritate your skin. These may include soaps and cleansers that are rough or cause drying; certain astringents, such as alcohol-containing products, soaps and toiletries containing alcohol, spices, or lime; or certain medicated soaps, shampoos, and hair permanent products. Do not use any other medicines with TRI-LUMA® Cream unless you have consulted your doctor. The medicines and product you have used in the past may cause redness or peeling when used with TRI-LUMA® .
What are the possible side effects of TRI-LUMA® Cream?
A very few patients may get severe allergic reactions from TRI-LUMA®. This includes people allergic to sulfites. They may have trouble breathing or severe asthma attacks, which can be life-threatening.
While you use TRI-LUMA® Cream, your skin may develop mild to moderate redness, peeling, burning, dryness, or itching.
TRI-LUMA® Cream contains a corticosteroid medicine as one of its active components. The following side effects have been reported with application of corticosteroid medicines to the skin: itching, irritation, dryness, infection of the hair follicles, acne, change in skin color, inflammation around the mouth, allergic skin reaction, skin infection, skin thinning, stretch marks, and sweat problems.
Stop using TRI-LUMA® Cream and contact your doctor if you have
Some patients using TRI-LUMA® Cream develop dark spots on their skin (hyperpigmentation), tingling, increased skin sensitivity, rash, acne, skin redness caused by a condition called rosacea, skin bumps, blisters, or tiny red lines or blood vessels showing through the skin (telangiectasia).
If you are concerned about how your skin is reacting to the medicine, call your doctor.
General information about prescription medicines
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use TRI-LUMA® for a condition for which it was not prescribed. Do not give TRI-LUMA® to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about TRI-LUMA® . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about TRI-LUMA ® that is written for health professionals.
Ingredients: TRI-LUMA® Cream contains fluocinolone acetonide, hydroquinone, and tretinoin as active ingredients, as well as the following in the cream base: butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth-10, methylparaben, PEG-100 stearate, propylparaben, purified water, sodium metabisulfite, stearic acid and stearyl alcohol.
Last updated on RxList: 10/10/2008
IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.
FLUOCINOLONE/TRETINOIN/HYDROQUINONE - TOPICAL
(FLOO-oh-SIN-oh-lone/tret-ih-NO-in/hi-dro-KWIN-own)
COMMON BRAND NAME(S): Tri-Luma
USES: This combination medication is used to treat melasma on the face. Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. It sometimes occurs with hormone changes. This product contains 3 different kinds of medication. Hydroquinone is a reversible skin bleaching agent. Tretinoin is a retinoid that increases skin shedding. Fluocinolone is a medium strength corticosteroid that reduces swelling, itching, and redness.
This medication may improve your melasma, but it is not a cure. Continued exposure to some of the causes of melasma (e.g., sunlight, estrogen-type birth control hormones) may cause it to return.
HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Before using, apply a small amount of this medicine to an area of unbroken skin, and check the area within 24 hours for any serious side effects. If the test area is itching, red, puffy, or blistering, do not use this product and contact your doctor. If there is just mild redness, then treatment with this product may begin.
Before using, gently wash your face and neck with a mild soapless cleanser. Rinse and pat dry the skin.
Apply a thin layer of medication to the affected area, including about 1/2 inch (1.5 centimeters) of normal-appearing skin around the affected area, once daily 30 minutes before bedtime or as directed by your doctor. Rub the medication into the skin gently and completely. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.
This medication may make the treated areas of skin more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen of SPF 30 or greater and wear protective clothing on the treated areas of skin when outdoors, even on cloudy or hazy days.
If you experience dry skin from using this product, you may use a skin moisturizer in the morning after washing your face. You may also use a moisturizer and cosmetics during the day while using this medication.
Avoid getting this product in your eyes or on the inside of your nose or mouth. If you do get this medication in those areas, flush with plenty of water. If severe irritation occurs, seek medical attention promptly.
Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each night.
It may take up to 4 weeks to notice significant improvement. However, this medication is not recommended for long-term use (e.g., longer than 8 weeks) without stopping the medication for short periods. Inform your doctor if your condition persists or worsens after 4 weeks of treatment.
Mild burning, stinging, redness, dryness, or acne may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering, skin cracking/shedding, "spider veins" (telangiectasia), stretch marks, other skin discoloration (besides melasma), "hair bumps" (folliculitis), blue-black darkening of the skin, numbness/tingling of hands/feet, increased pain/touch sensitivity.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using fluocinolone/tretinoin/hydroquinone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., hydrocortisone, prednisone) or sulfites; or if you have any other allergies.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma, open sores or broken areas of skin (especially on the face or hands), other skin conditions (e.g., eczema, psoriasis).
Though very unlikely, it is possible the fluocinolone in this product will be absorbed into your bloodstream. This may have undesirable consequences that may require additional corticosteroid treatment. This is especially true for children and those who have used this drug for an extended time, especially if they also have serious medical problems such as serious infections, injuries, or surgeries. This precaution applies for up to one year after stopping use of this drug. Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst/urination, unusual weakness, unusual weight loss, dizziness.
Consult your doctor or pharmacist for more details, and inform them that you use or have used this medication.
Too much bleaching of the skin might occur in some cases, resulting in an undesirable cosmetic effect in those with darker skin. Consult your doctor or pharmacist for more details.
This medication is not recommended for use during pregnancy. One medication in this product (tretinoin) has caused harm to an unborn baby when taken by mouth. Discuss the risks and benefits with your doctor.
It is not known whether these drugs pass into breast milk when applied to the skin. Consult your doctor before breast-feeding. Avoid skin-to-skin contact with your infant in areas where this product has been used.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other medicated skin products (e.g., soaps, cleansers, skin medications, skin-drying cosmetics), hormone-based birth control products (e.g., birth control pills, hormone implants), cosmetic products or drugs that increase the skin's sensitivity to the sun (e.g., tanning products, tetracyclines, quinolones such as ciprofloxacin).
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.
This medication has been prescribed for your current condition only. Do not use it later for another skin problem unless told to do so by your doctor. A different medication may be necessary in that case.
Laboratory and/or medical tests (e.g., adrenal gland function tests, morning cortisol blood test) may be performed periodically to monitor your progress or check for side effects, especially if you use this drug for an extended time, apply it over large areas of the body, or bandage/wrap the treated areas. Consult your doctor for more details.
Because this product contains a corticosteroid, inform all your doctors that you use or have used this product.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C). Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.
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