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



Status:Completed
Conditions:Psoriasis, Dermatology, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:2/17/2019
Start Date:December 15, 2015
End Date:September 9, 2016

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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.

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
We found this trial at
6
sites
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Phone: 919-781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Calgary, Alberta
Phone: 403-299-5821
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Fort Gratiot, Michigan 48059
Phone: 810-455-1612
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New York, New York 10155
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Philadelphia, Pennsylvania 19103
Phone: 215-563-7330
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West Dundee, Illinois 60118
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West Dundee, IL
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