Phase 3
Completed N=748
A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Source: ClinicalTrials.gov NCT03127956 ↗Enrolled (actual)
748
Serious AEs
1.1%
Results posted
Feb 2019
Primary outcomePrimary: Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions — 197; 124; 18; 402 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions |
197; 124; 18; 402; 518; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Signed informed consent or assent (for subjects under legal adult age)
- Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.
- Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol
- Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics.
Exclusion Criteria
- Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator
- Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study
Data sourced from ClinicalTrials.gov (NCT03127956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.