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| Name | Class |
|---|---|
| Accelovance | INDUSTRY |
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The purpose of this study is to evaluate the superiority in efficacy and assess safety and tolerability of the products S6G5T-3 and S6G5T-1 as compared to their respective active components or the vehicle for the treatment of acne.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S6G5T-3 | Experimental | topical cream |
|
| S6G5T-1 | Experimental | topical cream |
|
| S6G5T-5 | Active Comparator | topical cream |
|
| S6G5T-7 | Active Comparator | topical cream |
|
| S6G5T-6 | Active Comparator | topical cream |
|
| S6G5T-8 | Placebo Comparator | topical cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S6G5T-3 | Drug | once a day topical cream |
| |
| S6G5T-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) | Proportion of subjects with an assessment of clear or almost clear with at least a 2-grade improvement in IGA at Week 12 | week 12 |
| Absolute change in lesion count (separately for inflammatory and non-inflammatory) | Absolute change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions) | baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from Baseline in lesion count on the face at Week 12 | Percentage change from Baseline in lesion count on the face at Week 12 (separately for inflammatory and non-inflammatory lesions) | Baseline and week 12 |
| assessments of IGA at each time point |
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Inclusion Criteria:
Male and female subjects 9 years of age or older.
In good general health Based on medical records
Have a diagnosis of facial acne with >25 and <100 non-inflammatory lesions and >20 and <50 inflammatory lesions.
Have a score of "3" or "4" (Moderate or Severe) on the IGA scale.
Have two or fewer cysts or nodules (defined as an inflammatory lesion greater than or equal to 5 mm in diameter).
Sexually active women of child-bearing potential must use one of the following birth control options:
One of these highly effective contraception methods:
i. Intrauterine device (IUD); ii. Hormonal, for at least 3 months (Pills, injections, implants, transdermal patch, vaginal ring); iii. Tubal ligation; iv. Partner vasectomy,
OR A barrier form of contraception (listed below) i. Male or female condom; ii. Diaphragm with spermicides; iii. Cervical cap with spermicides; iv. Contraceptive sponge
Willingness and capacity for protocol compliance (for subjects under the age of consent, the parent/guardian must be willing and able to comply with study requirements).
Male subjects must be clean-shaven and agree to remain so for during the study visits.
Consent to participate, verified by signing an approved written Informed Consent Form and HIPAA; for subjects under the age of consent, both a signed assent form and a signed Informed Consent Form from the parent/guardian are required in accordance with local and federal regulations.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piyush Sheladia, M.S. | Accelovance | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Institute | Anaheim | California | 92801 | United States | ||
| Core Healthcare Group |
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| Drug |
once a day topical cream |
|
| S6G5T-5 | Drug | once a day topical cream |
|
| S6G5T-6 | Drug | once a day topical cream |
|
| S6G5T-7 | Drug | once a day topical cream |
|
| S6G5T-8 | Drug | once a day topical cream |
|
Supportive efficacy variables are the assessments of IGA percentage change at each time point during the treatment period, namely at Weeks 4, and 8. |
| baseline, week 4, 8 |
| Cerritos |
| California |
| 90703 |
| United States |
| eStudySite | Chula Vista | California | 91911 | United States |
| T. Joseph Raoof MD, Inc./Encino Research Center | Encino | California | 91436 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| eStudySite | Oceanside | California | 92056 | United States |
| Empire Clinical Research | Upland | California | 91786 | United States |
| Horizons Clinical Research Center, LLC | Denver | Colorado | 80220 | United States |
| MOORE Clinical Research, Inc | Brandon | Florida | 33511 | United States |
| Health Awareness, Inc. | Jupiter | Florida | 33458 | United States |
| LCC Medical Research Institute, LLC | Miami | Florida | 33126 | United States |
| Oceane7 Clinical Research | Miami | Florida | 33144 | United States |
| RM Medical Research, LLC | Miami | Florida | 33175 | United States |
| IMIC Inc. | Palmetto Bay | Florida | 33157 | United States |
| Clinical Research Trials of Florida, Inc. | Tampa | Florida | 33607 | United States |
| Meridien Research | Tampa | Florida | 33634 | United States |
| Heartland Research Associates, LLC | Augusta | Kansas | 67010 | United States |
| Dermatology Specialists Research | Louisville | Kentucky | 40202 | United States |
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| MediSearch clinical Trials | Saint Joseph | Missouri | 64506 | United States |
| Quality Clinical Research Inc. | Omaha | Nebraska | 68114 | United States |
| eStudySite | Las Vegas | Nevada | 89109 | United States |
| ActivMed Practices and Research, Inc. | Portsmouth | New Hampshire | 3801 | United States |
| New York Clinical Trials | Manhattan | New York | 10018 | United States |
| Derm Research Center of New York, Inc | Stony Brook | New York | 11790 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Paddington Testing Co, Inc | Philadelphia | Pennsylvania | 19103 | United States |
| Palmetto Clinical Trial Services, LLC @ Greenville Dermatology | Greenville | South Carolina | 29607 | United States |
| Discover Research, Inc. | Bryan | Texas | 77802 | United States |
| West Houston Clinical Research Services LLC | Houston | Texas | 77055 | United States |
| Austin Institute for Clinical Research, Inc. | Pflugerville | Texas | 78660 | United States |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | United States |
| 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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