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

NCT02655679 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2019-02-15

Study results available
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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.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

VTP-38543

VTP-38543 topical cream

OTHER

Vehicle with Transcutol®P

Vehicle matching VTP-38543 cream with Transcutol®P

OTHER

Vehicle without Transcutol®P

Vehicle matching VTP-38543 cream without Transcutol®P

Sponsors & Collaborators

  • Vitae Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Christy Harutunian · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-15
Primary Completion
2016-09-09
Completion
2016-09-09
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655679 on ClinicalTrials.gov