Trial · NCT03028363

A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

NCT03028363, Phase 3, Completed, Dermira, Inc.; results first posted 2019-02-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris. Trials, record NCT03028363. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03028363

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
NCT number: NCT03028363
Status: Completed
Phases: Phase 3
Enrollment: 759 participants, actual
Lead sponsor: Dermira, Inc.
Conditions: Acne Vulgaris
Interventions: Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
First posted: 2017-01-23
Last updated: 2021-07-20
Results first posted: 2019-02-05

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12	Baseline and Week 12	Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Primary	Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12	Baseline and Week 12	Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Primary	Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12	Baseline and Week 12	Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 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

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12	Baseline and Week 12	Intent-to-Treat	Lesions	LEAST_SQUARES_MEAN
PRIMARY	Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12	Baseline and Week 12	Intent-to-Treat	Lesions	LEAST_SQUARES_MEAN
PRIMARY	Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12	Baseline and Week 12	Intent-to-Treat	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12	Olumacostat Glasaretil Gel, 5.0%		-14.5	Standard Deviation 14.85	Lesions
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12	Olumacostat Glasaretil Gel, Vehicle		-13.5	Standard Deviation 14.54	Lesions
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12	Olumacostat Glasaretil Gel, 5.0%		-14.1	Standard Deviation 21.05	Lesions
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12	Olumacostat Glasaretil Gel, Vehicle		-11.8	Standard Deviation 20.28	Lesions
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12	Olumacostat Glasaretil Gel, 5.0%	Success	95		Participants
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12	Olumacostat Glasaretil Gel, Vehicle	Success	54		Participants
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12	Olumacostat Glasaretil Gel, 5.0%	Failure	403		Participants
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12	Olumacostat Glasaretil Gel, Vehicle	Failure	207		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Olumacostat Glasaretil Gel, 5.0%	498
Overall Study	STARTED	Olumacostat Glasaretil Gel, Vehicle	261
Overall Study	COMPLETED	Olumacostat Glasaretil Gel, 5.0%	420
Overall Study	COMPLETED	Olumacostat Glasaretil Gel, Vehicle	228
Overall Study	NOT COMPLETED	Olumacostat Glasaretil Gel, 5.0%	78
Overall Study	NOT COMPLETED	Olumacostat Glasaretil Gel, Vehicle	33

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Application site dryness	General disorders	Olumacostat Glasaretil Gel, 5.0%	13	485
other	Application site dryness	General disorders	Olumacostat Glasaretil Gel, Vehicle	2	258
other	Application site erythema	General disorders	Olumacostat Glasaretil Gel, 5.0%	13	485
other	Application site erythema	General disorders	Olumacostat Glasaretil Gel, Vehicle	3	258
other	Application site pain	General disorders	Olumacostat Glasaretil Gel, 5.0%	19	485
other	Application site pain	General disorders	Olumacostat Glasaretil Gel, Vehicle	11	258
other	Application site pruritus	General disorders	Olumacostat Glasaretil Gel, 5.0%	13	485
other	Application site pruritus	General disorders	Olumacostat Glasaretil Gel, Vehicle	4	258
other	Nasopharyngitis	Infections and infestations	Olumacostat Glasaretil Gel, 5.0%	15	485
other	Nasopharyngitis	Infections and infestations	Olumacostat Glasaretil Gel, Vehicle	5	258

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Olumacostat Glasaretil Gel, 5.0%	0	485
Total, all-cause mortality	Olumacostat Glasaretil Gel, Vehicle	0	258
Total, other adverse events	Olumacostat Glasaretil Gel, 5.0%	89	485
Total, other adverse events	Olumacostat Glasaretil Gel, Vehicle	33	258
Total, serious adverse events	Olumacostat Glasaretil Gel, 5.0%	1	485
Total, serious adverse events	Olumacostat Glasaretil Gel, Vehicle	3	258

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Olumacostat Glasaretil Gel, 5.0% vs Olumacostat Glasaretil Gel, Vehicle: deaths from any cause	Trial comparisons
Olumacostat Glasaretil Gel, 5.0% vs Olumacostat Glasaretil Gel, Vehicle: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03028363

GET https://conductscience.org/api/trials/v1/NCT03028363/registered

API reference For AI assistants