Differin Gel .3
"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
Differin Gel .3%
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne patients who used DIFFERIN Gel, 0.3% once daily for 12 weeks. Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with DIFFERIN Gel, 0.3% from the controlled clinical study is provided in the following table:
Table 1: Physician assessed local cutaneous irritation with
|Incidence of Local Cutaneous Irritation with DIFFERIN Gel,
0.3% from Controlled Clinical Study (N = 253*)
Maximum Severity Scores Higher Than Baseline
|Erythema||66 (26.1%)||33 (13.0%)||1 (0.4%)|
|Scaling||110 (43.5%)||47 (18.6%)||3 (1.2%)|
|Dryness||113 (44.7%)||43 (17.0%)||2 (0.8%)|
|Burning/Stinging||72 (28.5%)||36 (142%)||9 (3.6%)|
|* Total number of subjects with local cutaneous data for at least one post-Baseline evaluation.|
Table 2: Patient reported local cutaneous adverse reactions
with DIFFERIN Gel
|DIFFERIN (adapalene) Gel, 0.3%||Vehicle Gel|
|Related* Adverse Reactions||57(22.1%)||6 (4.5%)|
|Skin Discomfort||15(5.8%)||0 (0.0%)|
|* Selected adverse reactions defined by investigator as Possibly, Probably or Definitely Related|
Related adverse reactions from the controlled clinical trial that occurred in greater than 1% of patients who used DIFFERIN Gel, 0.3% once daily included: dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). The following selected adverse reactions occurred in less than 1% of patients: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
In a one-year, open-label safety study of 551 patients with acne who received DIFFERIN Gel, 0.3%, the pattern of adverse reactions was similar to the 12-week controlled study.
The following adverse reactions have been identified during post approval use of adapalene: skin irritation, application site pain, face edema, eyelid edema, lip swelling, and angioedema. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drag exposure.
Read the Differin Gel .3% (adapalene) Side Effects Center for a complete guide to possible side effects
Concomitant Topical Medications
As DIFFERIN Gel, 0.3% has the potential to induce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with DIFFERIN Gel, 0.3%. If these preparations have been used, it is advisable not to start therapy with DIFFERIN Gel, 0.3%, until the effects of such preparations have subsided.
No formal drug-drug interaction studies were conducted with DIFFERIN Gel, 0.3%.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/24/2010
Additional Differin Gel .3% Information
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