Acne Vulgaris
Conditions
Keywords
acne
Brief summary
The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.
Detailed description
Subjects with acne were randomized to one of four treatment groups for twice daily topical dosing to the face for 12 weeks. Assessments of acne status were performed at Baseline, Weeks 2, 4, 8 and 12 and then 4 weeks after the last dose of study drug.
Interventions
DRUGASC-J9 cream
Topical application to the face twice daily for 12 weeks.
DRUGplacebo
vehicle control applied topically twice daily for 12 weeks
Sponsors
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
* At least 12 years of age. * Facial acne, with: 20 -100 inflammatory facial lesions 20 -100 noninflammatory facial lesions No more than 2 nodules/cysts on the face
Exclusion criteria
* Women who are pregnant or breastfeeding * Skin diseases other than acne vulgaris * Use of oral retinoids within 6 months of Baseline Visit * Unwilling to discontinue all other treatments for facial acne * Unwilling to avoid excessive swimming/sun exposure and use of cosmetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 | Baseline to Week 12 | Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 | Baseline to Week 12 | The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne: 0 No acne lesions. 1. Rare non-inflammatory lesions. 2. Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions. 3. Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion. 4. Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions. 5. Highly inflammatory lesions, multiple nodulo-cystic lesions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Control Vehicle control cream applied topically to the face twice daily for 12 weeks | 47 |
| 0.001% ASC-J9 Cream 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks | 46 |
| 0.005% ASC-J9 Cream 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks | 47 |
| 0.025% ASC-J9 Cream 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks | 46 |
| Total | 186 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 4 | 1 | 4 |
| Overall Study | Protocol Violation | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 5 | 2 |
Baseline characteristics
| Characteristic | 0.001% ASC-J9 Cream | 0.005% ASC-J9 Cream | Vehicle Control | 0.025% ASC-J9 Cream | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 33 Participants | 32 Participants | 33 Participants | 31 Participants | 129 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 15 Participants | 14 Participants | 15 Participants | 57 Participants |
| Age Continuous | 18.0 years STANDARD_DEVIATION 4.9 | 17.7 years STANDARD_DEVIATION 5.8 | 17.7 years STANDARD_DEVIATION 4.9 | 18.3 years STANDARD_DEVIATION 5.3 | 17.9 years STANDARD_DEVIATION 5.2 |
| Region of Enrollment United States | 46 participants | 47 participants | 47 participants | 46 participants | 186 participants |
| Sex: Female, Male Female | 27 Participants | 19 Participants | 14 Participants | 16 Participants | 76 Participants |
| Sex: Female, Male Male | 19 Participants | 28 Participants | 33 Participants | 30 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 47 | 11 / 46 | 8 / 47 | 14 / 46 |
| serious Total, serious adverse events | 1 / 47 | 0 / 46 | 0 / 47 | 0 / 46 |
Outcome results
Primary
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.
Time frame: Baseline to Week 12
Population: ITT population: All randomized subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle Control | Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 | -37.4 Percent change | Standard Deviation 41 |
| 0.001% ASC-J9 Cream | Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 | -34.7 Percent change | Standard Deviation 32.4 |
| 0.005% ASC-J9 Cream | Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 | -30.7 Percent change | Standard Deviation 47.6 |
| 0.025% ASC-J9 Cream | Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12 | -44.8 Percent change | Standard Deviation 35.6 |
Secondary
Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12
The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne: 0 No acne lesions. 1. Rare non-inflammatory lesions. 2. Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions. 3. Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion. 4. Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions. 5. Highly inflammatory lesions, multiple nodulo-cystic lesions.
Time frame: Baseline to Week 12
Population: ITT population: All randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Control | Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 | 23 Participants |
| 0.001% ASC-J9 Cream | Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 | 20 Participants |
| 0.005% ASC-J9 Cream | Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 | 23 Participants |
| 0.025% ASC-J9 Cream | Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12 | 28 Participants |