An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis

• Status: Completed
• Trial end date: 2016-09-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vitae Pharmaceuticals, Inc.
• Treatments: Ether

Criteria

Inclusion Criteria:

• Mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (BSA) involvement

• Investigator Global Assessments (IGA) score of 2 or 3

• Body Mass Index (BMI) = 18 - 35 kg/m^2

• Negative Pregnancy test for females

Exclusion Criteria:

• Treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing.

• Organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and Electrocardiogram (ECG) findings

• Major surgery within 3 months of Screening

• Use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (AD), and topical products containing urea and/or ceramides within 14 prior to dosing

• Excessive sun exposures, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to dosing