Trial · NCT01936324
A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel
NCT01936324, Phase 1, Phase 2, Completed, Dermira, Inc.; results first posted 2019-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel. Trials, record NCT01936324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01936324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel
- NCT number
- NCT01936324
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 114 participants, actual
- Lead sponsor
- Dermira, Inc.
- Conditions
- Acne Vulgaris
- Interventions
- Olumacostat Glasaretil Gel, 7.5%, Olumacostat Glasaretil Gel, Vehicle
- First posted
- 2013-09-06
- Last updated
- 2021-07-20
- Results first posted
- 2019-05-10
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 in Phase 2a | Baseline and Week 12 | Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a |
| Primary | 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 |
| Primary | 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 |
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 in Phase 2a | 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 in Phase 2a | Baseline and Week 12 | Intent-to-Treat | Lesions | LEAST_SQUARES_MEAN |
| PRIMARY | 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 | 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 in Phase 2a | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | -19.865 | Standard Error 1.107 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | -14.296 | Standard Error 1.079 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | -20.131 | Standard Error 1.902 | Lesions | |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | -12.357 | Standard Error 1.856 | Lesions | |
| Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | Success | 13 | Participants | |
| Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | Success | 4 | Participants | |
| Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | Failure | 40 | Participants | |
| Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | Failure | 51 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 6 | |
| Overall Study | STARTED | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 53 | |
| Overall Study | STARTED | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 55 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 6 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 47 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 50 | |
| Overall Study | NOT COMPLETED | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 0 | |
| Overall Study | NOT COMPLETED | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 6 | |
| Overall Study | NOT COMPLETED | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 5 |
Source ClinicalTrials.gov
Adverse events21
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 | Application site dryness | General disorders | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 0 | 6 | |
| other | Application site dryness | General disorders | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 4 | 53 | |
| other | Application site dryness | General disorders | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 3 | 55 | |
| other | Application site erythema | General disorders | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 0 | 6 | |
| other | Application site erythema | General disorders | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 4 | 53 | |
| other | Application site erythema | General disorders | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 0 | 55 | |
| other | Application site pain | General disorders | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 0 | 6 | |
| other | Application site pain | General disorders | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 4 | 53 | |
| other | Application site pain | General disorders | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 3 | 55 | |
| other | Gastroenteritis | Infections and infestations | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 0 | 6 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 0 | 6 |
| Total, all-cause mortality | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 0 | 53 |
| Total, all-cause mortality | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 0 | 55 |
| Total, other adverse events | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 0 | 6 |
| Total, other adverse events | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 29 | 53 |
| Total, other adverse events | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 17 | 55 |
| Total, serious adverse events | Olumacostat Glasaretil Gel, 7.5%, Phase 1 | 0 | 6 |
| Total, serious adverse events | Olumacostat Glasaretil Gel, 7.5%, Phase 2a | 0 | 53 |
| Total, serious adverse events | Olumacostat Glasaretil Gel, Vehicle, Phase 2a | 1 | 55 |
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 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/NCT01936324
GET https://conductscience.org/api/trials/v1/NCT01936324/events?page=2