Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT03127956
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Study:
NCT03127956
Study Brief:
Protocol Section:
NCT03127956