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Decision from the Sponsor
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| Name | Class |
|---|---|
| Skin Laser & Surgery Specialists | OTHER |
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To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Scienceâ„¢ acne cream 2x or Next Scienceâ„¢ acne cream 1x in a double blind manner.
This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Scienceâ„¢ acne cream 2x or Next Scienceâ„¢ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acne cream 1x | Experimental | Twice-daily facial applications of the 1X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months. |
|
| Acne cream 2x | Experimental | Twice-daily facial applications of the 2X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acne cream 2X | Drug | Twice daily application of facial acne cream 2X after facial cleansing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Lesion Count | Inflammatory acne lesions with both study acne cream products after 6 months of treatment compared to baseline. This will be measured as the mean percent change from baseline to week 24 in the inflammatory lesion count. | Baseline versus 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Lesion count over time | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts | weeks 6, 12, 18, and 24 |
| Non-inflammatory acne lesion over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matt Myntti, PhD | Next Science | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Laser & Surgery Specialists of NY & NJ | Hackensack | New Jersey | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37077927 | Derived | Marshall-Hudson A, Tuley M, Damstra M, Dosik JS, Myntti MF, Porral D, Palomo J. A 6-month, Multi-center, Double-blind, Controlled Study to Evaluate the Effect of a Biofilm Disrupting Acne Cream on Mild-to-Moderate Facial Acne in Female Volunteer Subjects. J Clin Aesthet Dermatol. 2023 Apr;16(4):43-52. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2022 | |
| Reset | May 18, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2022 | May 18, 2023 |
| 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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| Acne cream 1X | Drug | Twice daily application of facial acne cream 1X after facial cleansing |
|
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts
| weeks 6, 12, 18, and 24 |
| Investigator Global Assessment over time | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA | weeks 6, 12, 18, and 24 |
| Treatment Areas over time | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in treatment areas (erythema, dryness, stinging or burning, erosion, edema, pain and itching) | weeks 6, 12, 18, and 24 |
| Quality of Life over time | The Acne-QoL questionnaire containing 19 questions organized into four domains which address the impact of facial acne on health-related quality of life will be administered. These are Self Perception, Role-social, Role-emotional and Acne Symptoms. Results will assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in QoL. | weeks 6, 12, 18, and 24 |