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A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Dose-ranging Study in the Treatment of Acne Vulgaris,
This will be a Phase 2, multicenter, randomized, double-blinded, dose-ranging, parallel arm comparison study in male and non-pregnant female subjects, 9 through 45 years of age (inclusive) with facial acne vulgaris. This dose-ranging study, intended to identify the dose(s), will consist of 7 study visits over 14 weeks:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VB-1953 topical gel - 2% QD | Experimental | VB-1953 topical gel - 2% QD |
|
| VB-1953 topical gel - 2% BID | Experimental | VB-1953 topical gel - 2% BID |
|
| VB-1953 topical gel- 0% (Vehicle) QD | Placebo Comparator | VB-1953 topical gel- 0% (Vehicle) QD |
|
| VB-1953 Vehicle | Placebo Comparator | VB-1953 topical gel- 0% (Vehicle) BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VB-1953 - 2% | Drug | Topical Gel |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory lesion counts | Absolute Change from Baseline in inflammatory lesion counts in each treatment arm at Week 12. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment of Inflammatory Acne (IGA) score | Proportion of subjects achieving success at Week 12, with success defined as Investigator's Global Assessment of Inflammatory Acne (IGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from Baseline. | 12 weeks |
| Percent change in inflammatory lesion counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Shilpi Jain | Vyome Therapeutics Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vyome Therapeutics Inc. | Ontario | California | 91762 | United States | ||
| Vyome Therapeutics Inc. |
Do not plan to share IPD.
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Parallel Assignment
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Triple (Participant, Care Provider, Investigator)
| VB-1953 - 0% (Vehicle) |
| Drug |
Topical Gel |
|
Percent change from Baseline in inflammatory lesion counts in each treatment arm at Week 12 |
| 12 weeks |
| Sherman Oaks |
| California |
| 91403 |
| United States |
| Vyome Therapeutics Inc. | Brandon | Florida | 33511 | United States |
| Vyome Therapeutics Inc. | Coral Gables | Florida | 33134 | United States |
| Vyome Therapeutics Inc | Miami | Florida | 33126 | United States |
| Vyome Therapeutics Inc. | Winter Park | Florida | 32792 | United States |
| Vyome Therapeutics Inc. | High Point | North Carolina | 27262 | United States |
| Vyome Therapeutics Inc. | Hazleton | Pennsylvania | 18201 | United States |
| Vyome Therapeutics Inc. | Upper Saint Clair | Pennsylvania | 15241 | United States |
| Vyome Therapeutics Inc. | Mt. Pleasant | South Carolina | 29464 | United States |
| Vyome Therapeutics Inc. | El Paso | Texas | 79902 | United States |
| Vyome Therapeutics Inc. | El Paso | Texas | 79928 | 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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| ID | Term |
|---|---|
| C000709180 | VB-1953 |
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