Acne Vulgaris
Conditions
Brief summary
The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris
Interventions
Gel containing Olumacostat Glasaretil
Vehicle (placebo) gel
Sponsors
Dermira, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent and, for subjects under legal adult age, signed assent * Age ≥ 9 years * Clinical diagnosis of facial acne vulgaris defined as: * At least 20 inflammatory lesions, and * At least 20 non-inflammatory lesions, and * Investigator Global Assessment of 3 or greater
Exclusion criteria
* Active cystic acne or acne conglobata, acne fulminans, and secondary acne * Two or more active nodulocystic lesions on the face * Clinically significant abnormal laboratory or ECG result * Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit * Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline * Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline * Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills). * Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline. * Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline * Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | Baseline and Week 12 | Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 |
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Baseline and Week 12 | Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 |
| Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 | Baseline and Week 12 | Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 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 |
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 for 12 weeks | 493 |
| Olumacostat Glasaretil Gel, Vehicle Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks | 251 |
| Total | 744 |
Baseline characteristics
| Characteristic | Olumacostat Glasaretil Gel, 5.0% | Olumacostat Glasaretil Gel, Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 304 Participants | 147 Participants | 451 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 189 Participants | 104 Participants | 293 Participants |
| Age, Continuous | 19.2 Years STANDARD_DEVIATION 6.98 | 19.2 Years STANDARD_DEVIATION 7.26 | 19.2 Years STANDARD_DEVIATION 7.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 88 Participants | 52 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 393 Participants | 196 Participants | 589 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants | 3 Participants | 15 Participants |
| Fitzpatrick Skin Type Type I | 33 Participants | 13 Participants | 46 Participants |
| Fitzpatrick Skin Type Type II | 99 Participants | 61 Participants | 160 Participants |
| Fitzpatrick Skin Type Type III | 133 Participants | 58 Participants | 191 Participants |
| Fitzpatrick Skin Type Type IV | 112 Participants | 57 Participants | 169 Participants |
| Fitzpatrick Skin Type Type V | 51 Participants | 26 Participants | 77 Participants |
| Fitzpatrick Skin Type Type VI | 65 Participants | 36 Participants | 101 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 9 Participants | 44 Participants |
| Race (NIH/OMB) Black or African American | 90 Participants | 54 Participants | 144 Participants |
| Race (NIH/OMB) More than one race | 21 Participants | 9 Participants | 30 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 342 Participants | 178 Participants | 520 Participants |
| Region of Enrollment Australia | 56 participants | 29 participants | 85 participants |
| Region of Enrollment Canada | 44 participants | 22 participants | 66 participants |
| Region of Enrollment United States | 393 participants | 200 participants | 593 participants |
| Sex: Female, Male Female | 294 Participants | 145 Participants | 439 Participants |
| Sex: Female, Male Male | 199 Participants | 106 Participants | 305 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 491 | 0 / 248 |
| other Total, other adverse events | 108 / 491 | 28 / 248 |
| serious Total, serious adverse events | 1 / 491 | 0 / 248 |
Outcome results
Primary
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Time frame: Baseline and Week 12
Population: Intent-to-Treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | -17.0 Lesions | Standard Deviation 12.16 |
| Olumacostat Glasaretil Gel, Vehicle | Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | -15.4 Lesions | Standard Deviation 11.95 |
p-value: 0.2301ANCOVA
Primary
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Time frame: Baseline and Week 12
Population: Intent-to-Treat
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | -18.0 Lesions | Standard Deviation 23.37 |
| Olumacostat Glasaretil Gel, Vehicle | Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | -17.6 Lesions | Standard Deviation 22.64 |
p-value: 0.6888ANCOVA
Primary
Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 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
Time frame: Baseline and Week 12
Population: Intent-to-Treat
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Olumacostat Glasaretil Gel, 5.0% | Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 | Success | 80 Participants |
| Olumacostat Glasaretil Gel, 5.0% | Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 | Failure | 413 Participants |
| Olumacostat Glasaretil Gel, Vehicle | Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 | Success | 30 Participants |
| Olumacostat Glasaretil Gel, Vehicle | Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 | Failure | 221 Participants |
p-value: 0.1361Regression, Logistic