Trial · NCT02431052
A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
NCT02431052, Phase 2, Completed, Dermira, Inc.; results first posted 2019-02-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris. Trials, record NCT02431052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02431052
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
- NCT number
- NCT02431052
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 420 participants, actual
- Lead sponsor
- Dermira, Inc.
- Conditions
- Acne Vulgaris
- Interventions
- Olumacostat Glasaretil, Vehicle
- First posted
- 2015-04-30
- Last updated
- 2021-07-20
- Results first posted
- 2019-02-26
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 group20
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, Vehicle QD | -10.5 | Standard Deviation 9.79 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, Vehicle BID | -11.0 | Standard Deviation 9.04 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, 4.0% QD | -14.6 | Standard Deviation 9.22 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, 7.5% QD | -14.5 | Standard Deviation 9.49 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, 7.5% BID | -15.0 | Standard Deviation 9.35 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, Vehicle QD | -9.3 | Standard Deviation 15.62 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, Vehicle BID | -9.3 | Standard Deviation 15.07 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, 4.0% QD | -15.3 | Standard Deviation 15.17 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, 7.5% QD | -13.4 | Standard Deviation 15.42 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Olumacostat Glasaretil Gel, 7.5% BID | -17.5 | Standard Deviation 15.15 | Lesions |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olumacostat Glasaretil Gel, Vehicle QD | 53 | |
| Overall Study | STARTED | Olumacostat Glasaretil Gel, Vehicle BID | 50 | |
| Overall Study | STARTED | Olumacostat Glasaretil Gel, 4.0% QD | 106 | |
| Overall Study | STARTED | Olumacostat Glasaretil Gel, 7.5% QD | 110 | |
| Overall Study | STARTED | Olumacostat Glasaretil Gel, 7.5% BID | 101 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, Vehicle QD | 42 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, Vehicle BID | 46 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, 4.0% QD | 94 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, 7.5% QD | 94 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, 7.5% BID | 86 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events10
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 | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Olumacostat Glasaretil Gel, Vehicle QD | 0 | 52 | |
| other | Nasopharyngitis | Infections and infestations | Olumacostat Glasaretil Gel, Vehicle BID | 0 | 50 | |
| other | Nasopharyngitis | Infections and infestations | Olumacostat Glasaretil Gel, 4.0% QD | 4 | 106 | |
| other | Nasopharyngitis | Infections and infestations | Olumacostat Glasaretil Gel, 7.5% QD | 6 | 109 | |
| other | Nasopharyngitis | Infections and infestations | Olumacostat Glasaretil Gel, 7.5% BID | 7 | 101 | |
| serious | Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Olumacostat Glasaretil Gel, Vehicle QD | 0 | 52 | |
| serious | Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Olumacostat Glasaretil Gel, Vehicle BID | 0 | 50 | |
| serious | Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Olumacostat Glasaretil Gel, 4.0% QD | 0 | 106 | |
| serious | Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Olumacostat Glasaretil Gel, 7.5% QD | 1 | 109 | |
| serious | Uterine Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Olumacostat Glasaretil Gel, 7.5% BID | 0 | 101 |
Source ClinicalTrials.gov
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olumacostat Glasaretil Gel, Vehicle QD | 0 | 52 |
| Total, all-cause mortality | Olumacostat Glasaretil Gel, Vehicle BID | 0 | 50 |
| Total, all-cause mortality | Olumacostat Glasaretil Gel, 4.0% QD | 0 | 106 |
| Total, all-cause mortality | Olumacostat Glasaretil Gel, 7.5% QD | 0 | 109 |
| Total, all-cause mortality | Olumacostat Glasaretil Gel, 7.5% BID | 0 | 101 |
| Total, other adverse events | Olumacostat Glasaretil Gel, Vehicle QD | 0 | 52 |
| Total, other adverse events | Olumacostat Glasaretil Gel, Vehicle BID | 0 | 50 |
| Total, other adverse events | Olumacostat Glasaretil Gel, 4.0% QD | 4 | 106 |
| Total, other adverse events | Olumacostat Glasaretil Gel, 7.5% QD | 6 | 109 |
| Total, other adverse events | Olumacostat Glasaretil Gel, 7.5% BID | 7 | 101 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT02431052
GET https://conductscience.org/api/trials/v1/NCT02431052/registered