Dermatitis, Atopic Clinical Trial
Official title:
A Randomized, Double-Blind, Vehicle-Controlled Ascending Multiple Dose and Clinical Proof-Of-Concept Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VTP-38543 in Adult Patients With Mild to Moderate Atopic Dermatitis
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.
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.
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