Trial · NCT03127956
A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
NCT03127956, 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 Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris. Trials, record NCT03127956. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03127956
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
- NCT number
- NCT03127956
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 748 participants, actual
- Lead sponsor
- Dermira, Inc.
- Conditions
- Acne Vulgaris
- Interventions
- Olumacostat Glasaretil Gel, 5.0%
- First posted
- 2017-04-25
- Last updated
- 2021-07-20
- Results first posted
- 2019-02-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Day 1 - Week 36 | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Day 1 - Week 36 | Safety Population | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Adverse Events (Mild) | 197 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Adverse Events (Moderate) | 124 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Adverse Events (Severe) | 18 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Adverse Events (Not Reported) | 402 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Burning/Stinging (None) | 518 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Burning/Stinging (Mild) | 11 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Burning/Stinging (Moderate) | 2 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Burning/Stinging (Severe) | 0 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Burning/Stinging (Not Reported) | 210 | Participants | |
| Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Olumacostat Glasaretil Gel, 5.0% | Pruritus (None) | 500 | Participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olumacostat Glasaretil Gel, 5.0% | 748 | |
| Overall Study | COMPLETED | Olumacostat Glasaretil Gel, 5.0% | 431 | |
| Overall Study | NOT COMPLETED | Olumacostat Glasaretil Gel, 5.0% | 317 |
Source ClinicalTrials.gov
Adverse events17
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, 5.0% | 28 | 741 | |
| other | Application site erythema | General disorders | Olumacostat Glasaretil Gel, 5.0% | 25 | 741 | |
| other | Application site pain | General disorders | Olumacostat Glasaretil Gel, 5.0% | 29 | 741 | |
| other | Application site pruritus | General disorders | Olumacostat Glasaretil Gel, 5.0% | 39 | 741 | |
| other | Influenza | Infections and infestations | Olumacostat Glasaretil Gel, 5.0% | 16 | 741 | |
| other | Nasopharyngitis | Infections and infestations | Olumacostat Glasaretil Gel, 5.0% | 49 | 741 | |
| other | Upper respiratory tract infection | Infections and infestations | Olumacostat Glasaretil Gel, 5.0% | 57 | 741 | |
| other | Sunburn | Injury, poisoning and procedural complications | Olumacostat Glasaretil Gel, 5.0% | 19 | 741 | |
| other | Headache | Nervous system disorders | Olumacostat Glasaretil Gel, 5.0% | 19 | 741 | |
| serious | Infectious mononucleosis | Infections and infestations | Olumacostat Glasaretil Gel, 5.0% | 1 | 741 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olumacostat Glasaretil Gel, 5.0% | 0 | 741 |
| Total, other adverse events | Olumacostat Glasaretil Gel, 5.0% | 281 | 741 |
| Total, serious adverse events | Olumacostat Glasaretil Gel, 5.0% | 8 | 741 |
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/NCT03127956
GET https://conductscience.org/api/trials/v1/NCT03127956/results?page=2