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In human dermal safety studies, tazarotene 0.05% and 0.1% creams did not induce allergic contact sensitization, phototoxicity or photoallergy.
The most frequent treatment-related adverse reactions ( ≥ 5%) reported during the clinical trials with AVAGE® (TAZAROTENE) Cream 0.1% in the treatment of facial fine wrinkling, mottled hypo- and hyperpigmentation, and benign facial lentigines were limited to the skin. Those occurring in >10%, in descending order, included: desquamation, erythema, burning sensation, and dry skin. Events occurring in ≥ 1% to ≤ 10% of patients, in descending order included: skin irritation, pruritus, irritant contact dermatitis, stinging, acne, rash or cheilitis. Common adverse events observed in the clinical trials are presented in the following table:
TABLE OF ADVERSE EVENTS SEEN IN CLINICAL TRIALS WITH AVAGE®
(TAZAROTENE) Cream 0.1%
| Adverse Event | AVAGE ® N=567 |
Vehicle N=564 |
| Desquamation | 40% | 3% |
| Erythema | 34% | 3% |
| BurningSensation | 26% | <1% |
| DrySkin | 16% | 3% |
| Irritation Skin | 10% | 1% |
| Pruritus | 10% | 1% |
| Irritant Contact Dermatitis | 8% | 1% |
| Stinging | 3% | <1% |
| Acne | 3% | 3% |
| Rash | 3% | 1% |
| Cheilitis | 1% | 0% |
A few patients reported adverse events at Week 0; however, for patients who were treated with AVAGE® (tazarotene) the highest number of new reports for each adverse event was at Week 2.
When combining data from the two pivotal studies, 5.3% of patients in the tazarotene cream group and 0.9% of patients in the vehicle group discontinued due to adverse events.
Overall, 20/567 (3.5%) patients in the AVAGE® (TAZAROTENE) Cream 0.1% group and 16/564 (2.8%) patients in the vehicle group reported adverse events (including edema, irritation, and inflammation) directly related to the eye or eyelid. The majority of these conditions were mild.
Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to “rest” a patient's skin until the effects of such preparations subside before use of AVAGE® (tazarotene) Cream is begun.
Last reviewed on RxList: 10/8/2008
This monograph has been modified to include the generic and brand name in many instances.
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