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The purpose of this study is to evaluate if topical ASC-J9 cream is effective in treating acne.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Vehicle control cream applied topically to the face twice daily for 12 weeks |
|
| 2 | Experimental | 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
|
| 3 | Experimental | 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
|
| 4 | Experimental | 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC-J9 cream | Drug | Topical application to the face twice daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Charles CY Shih, PhD | AndroScience Corp | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bay Dermatology Medical Group | Fremont | California | 94538 | United States | ||
| Therapeutics Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle Control | Vehicle control cream applied topically to the face twice daily for 12 weeks |
| FG001 | 0.001% ASC-J9 Cream | 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| FG002 | 0.005% ASC-J9 Cream | 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| FG003 | 0.025% ASC-J9 Cream | 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle Control | Vehicle control cream applied topically to the face twice daily for 12 weeks |
| BG001 | 0.001% ASC-J9 Cream | 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT population: All randomized subjects | Posted | Mean | Standard Deviation | Percent change | Baseline to Week 12 |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle Control | Vehicle control cream applied topically to the face twice daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral meningitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles CY Shih, PhD | AndroScience Corp | (858) 638-7230 | cyshih@androscience.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| placebo | Drug | vehicle control applied topically twice daily for 12 weeks |
|
|
| Baseline to Week 12 |
| San Diego |
| California |
| 92123 |
| United States |
| Northwest Clinical Trial | Boise | Idaho | 83704 | United States |
| TKL Research, Inc | Paramus | New Jersey | 07652 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Dermatology Associates | Knoxville | Tennessee | 37934 | United States |
| DermResearch, Inc | Austin | Texas | 78759 | United States |
| J&S Studies, Inc | Bryan | Texas | 77802 | United States |
| Dermatology Research Center, Inc | Salt Lake City | Utah | 84124 | United States |
| Education and Research Foundation | Lynchburg | Virginia | 24501 | United States |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | 0.005% ASC-J9 Cream | 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| BG003 | 0.025% ASC-J9 Cream | 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 0.005% ASC-J9 Cream | 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
| OG003 | 0.025% ASC-J9 Cream | 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks |
|
|
| 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.
| ITT population: All randomized subjects | Posted | Number | Participants | Baseline to Week 12 |
|
|
|
| 1 |
| 47 |
| 5 |
| 47 |
| EG001 | 0.001% ASC-J9 Cream | 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks | 0 | 46 | 11 | 46 |
| EG002 | 0.005% ASC-J9 Cream | 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks | 0 | 47 | 8 | 47 |
| EG003 | 0.025% ASC-J9 Cream | 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks | 0 | 46 | 14 | 46 |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.