Who is sponsoring NCT01936324?

NCT01936324 is sponsored by Dermira, Inc..

What condition does NCT01936324 study?

NCT01936324 studies Acne Vulgaris.

What drugs are being tested in NCT01936324?

Interventions: Olumacostat Glasaretil Gel, 7.5%, Olumacostat Glasaretil Gel, Vehicle.

What is the status of NCT01936324?

NCT01936324 is currently COMPLETED.

Last reviewed 2021-07-16 · How we verify

A Study of the Safety, Tolerability and Preliminary Efficacy of DRM01B Topical Gel in Healthy Volunteers and Subjects With Acne Vulgaris

NCT01936324 Phase 1/Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Dermira, Inc.
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	114
Start date	2013-08
Completion	2014-06

Conditions

Acne Vulgaris

Interventions

Olumacostat Glasaretil Gel, 7.5%
Olumacostat Glasaretil Gel, Vehicle

Primary outcomes

Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a — Baseline and Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a — Baseline and Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a — Baseline and Week 12
Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions

Countries

Canada