Acne Vulgaris
Conditions
Brief summary
The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris
Interventions
Gel containing Olumacostat Glasaretil
Sponsors
Dermira, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face | 741 |
| Total | 741 |
Baseline characteristics
| Characteristic | Olumacostat Glasaretil Gel, 5.0% |
|---|---|
| Age, Categorical <=18 years | 446 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 295 Participants |
| Age, Continuous | 19.3 Years STANDARD_DEVIATION 7.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 211 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 522 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 26 Participants |
| Race (NIH/OMB) Black or African American | 133 Participants |
| Race (NIH/OMB) More than one race | 29 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 546 Participants |
| Region of Enrollment Australia | 86 participants |
| Region of Enrollment Canada | 30 participants |
| Region of Enrollment United States | 625 participants |
| Sex: Female, Male Female | 423 Participants |
| Sex: Female, Male Male | 318 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 741 |
| other Total, other adverse events | 281 / 741 |
| serious Total, serious adverse events | 8 / 741 |
Outcome results
Primary
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Time frame: Day 1 - Week 36
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Peeling (Mild) | 22 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Adverse Events (Mild) | 197 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Adverse Events (Moderate) | 124 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Adverse Events (Severe) | 18 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Adverse Events (Not Reported) | 402 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Burning/Stinging (None) | 518 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Burning/Stinging (Mild) | 11 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Burning/Stinging (Moderate) | 2 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Burning/Stinging (Severe) | 0 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Burning/Stinging (Not Reported) | 210 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Pruritus (None) | 500 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Pruritus (Mild) | 29 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Pruritus (Moderate) | 2 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Pruritus (Severe) | 0 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Pruritus (Not Reported) | 210 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Erythema (None) | 469 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Erythema (Mild) | 55 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Erythema (Moderate) | 7 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Erythema (Severe) | 0 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Erythema (Not Reported) | 210 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Dryness (None) | 485 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Dryness (Mild) | 43 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Dryness (Moderate) | 3 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Dryness (Severe) | 0 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Dryness (Not Reported) | 210 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Peeling (None) | 507 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Peeling (Moderate) | 1 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Peeling (Severe) | 0 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions | Peeling (Not Reported) | 211 Participants |