Aklief Adverse Reactions

As a measure of tolerance, summary of safety profile, local cutaneous reactions such as erythema, scaling, dryness, and stinging/ burning) were collected separately from other adverse events as a measure of local tolerance. These cutaneous reactions are very common and of mild, moderate and severe intensity for up to 39%, 29.7% and 6.2% of patients, respectively on the face. On the trunk, up to 32.9%, 18.9%, 5.2% of patients had mild, moderate and severe reactions respectively. The maximum severity typically occurred at Week 1 for the face, and at Week 2 to 4 for the trunk, and decreased with continued use of the medication.
The most "commonly" reported adverse reaction as described as follows in the table are application site irritation, application site pruritus and sunburn, occurring in 1.2% to 6.5% of patients treated with Trifarotene (Aklief) cream in clinical studies.
Tabulated summary of adverse reactions: Adverse reactions reported in the 12-week vehicle-controlled Phase 3 studies in 1220 patients treated with Aklief cream (and for which the rate for Aklief cream exceeds the rate for vehicle cream) are presented in the table.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to 1<100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). (See table.)

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A phase IV study, including a total of 202 subjects was completed in the USA and Puerto Rico. Upon review of the study results, no new safety signal has been identified. The events reported in the study are consistent with the safety profile of triafarotene cream.