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A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel

NCT01936324 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2021-07-20

Study results available
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Summary

This is a Phase 1/2a study.

The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers.

The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Olumacostat Glasaretil Gel, 7.5%

Gel containing Olumacostat Glasaretil

OTHER

Olumacostat Glasaretil Gel, Vehicle

Vehicle (placebo) gel

Sponsors & Collaborators

  • Dermira, Inc.

    lead INDUSTRY

Principal Investigators

  • Janice Drew · Dermira, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • 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 NCT01936324 on ClinicalTrials.gov