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

NCT ID: NCT02655679

Last Updated: 2019-02-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2016-09-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VTP-38543 0.05%

VTP-38543 0.05% administered topically every 12 hours for 28 days.

Group Type EXPERIMENTAL

VTP-38543

Intervention Type DRUG

VTP-38543 topical cream

VTP-38543 0.15%

VTP-38543 0.15% administered topically every 12 hours for 28 days.

Group Type EXPERIMENTAL

VTP-38543

Intervention Type DRUG

VTP-38543 topical cream

Vehicle without Transcutol®P

Vehicle without Transcutol®P administered topically every 12 hours for 28 days.

Group Type PLACEBO_COMPARATOR

Vehicle without Transcutol®P

Intervention Type OTHER

Vehicle matching VTP-38543 cream without Transcutol®P

VTP-38543 1%

VTP-38543 1% administered topically every 12 hours for 28 days.

Group Type EXPERIMENTAL

VTP-38543

Intervention Type DRUG

VTP-38543 topical cream

Vehicle with Transcutol®P

Vehicle with Transcutol®P administered topically every 12 hours for 28 days.

Group Type PLACEBO_COMPARATOR

Vehicle with Transcutol®P

Intervention Type OTHER

Vehicle matching VTP-38543 cream with Transcutol®P

Interventions

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VTP-38543

VTP-38543 topical cream

Intervention Type DRUG

Vehicle with Transcutol®P

Vehicle matching VTP-38543 cream with Transcutol®P

Intervention Type OTHER

Vehicle without Transcutol®P

Vehicle matching VTP-38543 cream without Transcutol®P

Intervention Type OTHER

Other Intervention Names

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Transcutol®P is Diethylene Glycol Monoethyl Ether, NF. Transcutol®P is Diethylene Glycol Monoethyl Ether, NF.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitae Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christy Harutunian

Role: STUDY_DIRECTOR

Allergan

Locations

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Dundee Dermatology

West Dundee, Illinois, United States

Site Status

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Site Status

Skin Specialty Dermatology

New York, New York, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Paddington Testing Company, Inc

Philadelphia, Pennsylvania, United States

Site Status

Kirk Barber Research

Calgary, Alberta, Canada

Site Status

Stratica Medical Inc

Edmonton, Alberta, Canada

Site Status

Lynderm Research Inc

Markham, Ontario, Canada

Site Status

The Center for Dermatology / Institution

Richmond Hill, Ontario, Canada

Site Status

Windsor Clinical Research Inc

Windsor, Ontario, Canada

Site Status

Dr Isabelle Delorme Inc

Drummondville, Quebec, Canada

Site Status

Innovaderm Research

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Czarnowicki T, Dohlman AB, Malik K, Antonini D, Bissonnette R, Chan TC, Zhou L, Wen HC, Estrada Y, Xu H, Bryson C, Shen J, Lala D, Ma'ayan A, McGeehan G, Gregg R, Guttman-Yassky E. Effect of short-term liver X receptor activation on epidermal barrier features in mild to moderate atopic dermatitis: A randomized controlled trial. Ann Allergy Asthma Immunol. 2018 Jun;120(6):631-640.e11. doi: 10.1016/j.anai.2018.03.013. Epub 2018 Mar 19.

Reference Type DERIVED
PMID: 29567358 (View on PubMed)

Other Identifiers

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VTP-38543-001

Identifier Type: -

Identifier Source: org_study_id

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