Acne
Conditions
Keywords
androgen receptor degradation enhancer
Brief summary
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.
Detailed description
Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.
Interventions
DRUGASC-J9
Cream for twice daily topical application to the face
Sponsors
Orient Europharma Co., Ltd.
AndroScience Corp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * At least 12 years of age at the time of enrollment * Facial acne, with: 1. 20-60 inflammatory facial lesions (papules/pustules/nodules/cysts); 2. 20-100 noninflammatory facial lesions (open and closed comedones); 3. No more than 2 nodules/cysts on the face (defined as an inflammatory lesion greater than or equal to 5 mm in diameter); 4. Investigator's Global Assessment (IGA) acne score of 3 or 4. Key
Exclusion criteria
* Females who are pregnant or breast-feeding * Skin diseases other than acne vulgaris * Use of other topical or systemic treatments for acne * Other significant medical conditions or clinically significant abnormal laboratory test results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Inflammatory Acne Lesion Counts | 12 weeks | Percent change from Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success on Investigator Global Assessment (IGA) at Week 12 | 12 weeks | Overall acne rated as clear, almost clear, mild, moderate, severe, very severe. Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline |
| Percent Change in Noninflammatory Acne Lesion Counts | 12 weeks | Percent change from Baseline |
Countries
Taiwan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Control Cream ASC-J9: Cream for twice daily topical application to the face | 58 |
| 0.025% ASC-J9 Cream ASC-J9: Cream for twice daily topical application to the face | 60 |
| 0.1% ASC-J9 Cream ASC-J9: Cream for twice daily topical application to the face | 63 |
| Total | 181 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 4 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
| Overall Study | Subject wanted alternate treatment | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Vehicle Control Cream | 0.025% ASC-J9 Cream | 0.1% ASC-J9 Cream |
|---|---|---|---|---|
| Age, Categorical <=18 years | 58 Participants | 18 Participants | 18 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 123 Participants | 40 Participants | 42 Participants | 41 Participants |
| Age, Continuous | 21.3 Years STANDARD_DEVIATION 5.6 | 21.1 Years STANDARD_DEVIATION 5.7 | 20.7 Years STANDARD_DEVIATION 4.8 | 22.0 Years STANDARD_DEVIATION 6.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 176 Participants | 56 Participants | 58 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 141 Participants | 44 Participants | 48 Participants | 49 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 35 Participants | 14 Participants | 10 Participants | 11 Participants |
| Region of Enrollment Taiwan | 139 participants | 44 participants | 47 participants | 48 participants |
| Region of Enrollment United States | 42 participants | 14 participants | 13 participants | 15 participants |
| Sex: Female, Male Female | 86 Participants | 31 Participants | 23 Participants | 32 Participants |
| Sex: Female, Male Male | 95 Participants | 27 Participants | 37 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 60 | 0 / 63 |
| serious Total, serious adverse events | 0 / 58 | 0 / 60 | 0 / 63 |
Outcome results
Primary
Percent Change in Inflammatory Acne Lesion Counts
Percent change from Baseline
Time frame: 12 weeks
Population: All randomized patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Control Cream | Percent Change in Inflammatory Acne Lesion Counts | -28.6 Percentage change from baseline | Standard Deviation 52.2 |
| 0.025% ASC-J9 Cream | Percent Change in Inflammatory Acne Lesion Counts | -44.3 Percentage change from baseline | Standard Deviation 31.7 |
| 0.1% ASC-J9 Cream | Percent Change in Inflammatory Acne Lesion Counts | -44.4 Percentage change from baseline | Standard Deviation 34.6 |
p-value: 0.1919Cochran-Mantel-Haenszel
Secondary
Percent Change in Noninflammatory Acne Lesion Counts
Percent change from Baseline
Time frame: 12 weeks
Population: All randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Control Cream | Percent Change in Noninflammatory Acne Lesion Counts | -18.5 Percentage change from baseline | Standard Deviation 49.7 |
| 0.025% ASC-J9 Cream | Percent Change in Noninflammatory Acne Lesion Counts | -35.5 Percentage change from baseline | Standard Deviation 39.7 |
| 0.1% ASC-J9 Cream | Percent Change in Noninflammatory Acne Lesion Counts | -36.3 Percentage change from baseline | Standard Deviation 38.6 |
p-value: 0.0857Cochran-Mantel-Haenszel
Secondary
Success on Investigator Global Assessment (IGA) at Week 12
Overall acne rated as clear, almost clear, mild, moderate, severe, very severe. Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline
Time frame: 12 weeks
Population: All randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Control Cream | Success on Investigator Global Assessment (IGA) at Week 12 | 6.9 Percentage of subjects |
| 0.025% ASC-J9 Cream | Success on Investigator Global Assessment (IGA) at Week 12 | 21.7 Percentage of subjects |
| 0.1% ASC-J9 Cream | Success on Investigator Global Assessment (IGA) at Week 12 | 17.5 Percentage of subjects |
p-value: 0.061Cochran-Mantel-Haenszel