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

Completed · Phase 1/Phase 2

Conditions studied: Dermatitis, Atopic

In brief

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.

Key facts

Study ID

NCT02655679

Run by

Vitae Pharmaceuticals, Inc.

People needed

104

Starts

2015-12-15

Expected to finish

2016-09-09

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dundee Dermatology — West Dundee, Illinois, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Skin Specialty Dermatology — New York, New York, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Paddington Testing Company, Inc — Philadelphia, Pennsylvania, United States
• Kirk Barber Research — Calgary, Alberta, Canada
• Stratica Medical Inc — Edmonton, Alberta, Canada
• Lynderm Research Inc — Markham, Ontario, Canada
• The Center for Dermatology / Institution — Richmond Hill, Ontario, Canada
• Windsor Clinical Research Inc — Windsor, Ontario, Canada
• Dr Isabelle Delorme Inc — Drummondville, Quebec, Canada
• Innovaderm Research — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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