pivotal phase 3 AD trial program (ADORING). However, the
exaggerated test conditions and dosing frequencies used in
these 4 phase 1 trials vary.
MATERIALS AND METHODS
Trial Designs and Participants
Four separate, single-center, randomized, controlled, withinparticipant comparison trials were conducted to evaluate cumulative skin irritation, skin sensitization, potential for photoallergy, and potential for phototoxicity with topical administration of tapinarof cream 1% compared with vehicle and other relevant controls in healthy volunteers (Table 1).
Fully occlusive patch conditions were used in the first trial investigating cumulative skin irritation to assess worst-case conditions. Semi-occlusive patch conditions were used in the other 3 trials, and dermal responses were evaluated during the challenge phase for the skin sensitization and photoallergy trials and in the post-dose phase for the phototoxicity trial. A semiocclusive patch was used to limit topical irritation during the induction phase and maximize successful completion of the subsequent challenge.
Approximately 0.2 mL of tapinarof cream 1%, vehicle or controls were dispensed onto patches and applied to test application sites on the infrascapular area of the back by study personnel in each trial. In all studies, assessments of skin irritation were conducted by a trained evaluator who was blinded to treatment. In addition to dermal safety assessments, the incidence of adverse events (AEs) was reported.
Participants were adults of any Fitzpatrick skin type or race in the skin sensitization and cumulative skin irritation trials; and adults with Fitzpatrick skin types I, II, or III in the phototoxicity and photoallergy trials. Key exclusion criteria for all trials were (i) a diagnosis or history of psoriasis, active AD/eczema, or visible skin disease at the application site; and (ii) use of systemic or topical corticosteroids within 3 weeks prior to day 1.
All participants provided written informed consent and trials
Four separate, single-center, randomized, controlled, withinparticipant comparison trials were conducted to evaluate cumulative skin irritation, skin sensitization, potential for photoallergy, and potential for phototoxicity with topical administration of tapinarof cream 1% compared with vehicle and other relevant controls in healthy volunteers (Table 1).
Fully occlusive patch conditions were used in the first trial investigating cumulative skin irritation to assess worst-case conditions. Semi-occlusive patch conditions were used in the other 3 trials, and dermal responses were evaluated during the challenge phase for the skin sensitization and photoallergy trials and in the post-dose phase for the phototoxicity trial. A semiocclusive patch was used to limit topical irritation during the induction phase and maximize successful completion of the subsequent challenge.
Approximately 0.2 mL of tapinarof cream 1%, vehicle or controls were dispensed onto patches and applied to test application sites on the infrascapular area of the back by study personnel in each trial. In all studies, assessments of skin irritation were conducted by a trained evaluator who was blinded to treatment. In addition to dermal safety assessments, the incidence of adverse events (AEs) was reported.
Participants were adults of any Fitzpatrick skin type or race in the skin sensitization and cumulative skin irritation trials; and adults with Fitzpatrick skin types I, II, or III in the phototoxicity and photoallergy trials. Key exclusion criteria for all trials were (i) a diagnosis or history of psoriasis, active AD/eczema, or visible skin disease at the application site; and (ii) use of systemic or topical corticosteroids within 3 weeks prior to day 1.
All participants provided written informed consent and trials
