Conditions: Dermatitis, Atopic
Keywords: Eczema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 104
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

Detailed description:
This is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 following twice-daily, every twelve hours (Q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

Evaluation of three ascending doses in three dose panels is planned for this trial. Dose Panel 1 (VTP-38543 0.05%) and Panel 2 (VTP-38543 0.15%) will each enroll 30 participants and randomize 20 to VTP-38543 and 10 to matching vehicle control (Vehicle without Transcutol®P). Dose Panel 3 (VTP-38543 1%) will enroll 40 participants and randomize 20 to VTP-38543 and 20 to matching vehicle control (Vehicle with Transcutol®P). A total of approximately 100 participants will participate in the trial.

Arms:
arm 1: VTP-38543 0.05% administered topically every 12 hours for 28 days. arm 2: VTP-38543 0.15% administered topically every 12 hours for 28 days. arm 3: Vehicle without Transcutol®P administered topically every 12 hours for 28 days. arm 4: VTP-38543 1% administered topically every 12 hours for 28 days. arm 5: Vehicle with Transcutol®P administered topically every 12 hours for 28 days.

Interventions: intervention 1: VTP-38543 intervention 2: Vehicle with Transcutol®P intervention 3: Vehicle without Transcutol®P
Intervention descriptions: intervention 1: VTP-38543 topical cream intervention 2: Vehicle matching VTP-38543 cream with Transcutol®P intervention 3: Vehicle matching VTP-38543 cream without Transcutol®P

Protocol document: