ADVERSE REACTIONS:
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% |
| Burning Sensation | 26% | <1% |
| Dry skin | 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® 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.
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