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The overall objective of this study is to assess how the use of the drug may shift the skin microbiome and skin biophysical properties. Specifically, the study objectives were to assess the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug | Experimental | Daily Encapsulated Benzoyl Peroxide (E-BPO) Cream, for 8 weeks (period 1). Subjects will then switch treatments to the vehicle cream for a period of 4 weeks (period 2), |
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| Vehicle | Placebo Comparator | Daily Vehicle Cream, for 8 weeks (period 1). Subjects will then switch treatments to the study drug encapsulated E-BPO for a period of 4 weeks (period 2), |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encapsulated Benzoyl Peroxide Cream | Drug | Subjects will use a "pea-size" amount for each area of the face |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin microbiome diversity after 8-weeks of treatment compared to baseline | Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs. | 8-weeks |
| Change in transepidermal water loss after 8-weeks of treatment compared to baseline. | transepidermal water loss in g/m2/h | 8-weeks |
| Change in stratum corneum hydration after 8-weeks of treatment compared to baseline. | stratum corneum water content (wt%) | 8-weeks |
| Change in sebum excretion rate after 8-weeks of treatment compared to baseline. | sebum production in µg/cm2 | 8-weeks |
| Change in colorimeter test after 8-weeks of treatment compared to baseline. | facial L*a*b* values | 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline | Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs. | 4-weeks |
| Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integrative Skin Science and Research (ISSR) | Sacramento | California | 95815 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39148964 | Derived | Nong Y, Sugarman J, York JP, Levy-Hacham O, Nadora D, Mizrahi R, Galati A, Gallo RL, Sivamani RK. Effect of Topical Microencapsulated Benzoyl Peroxide on the Skin Microbiome in Rosacea: A Randomized, Double-Blind, Crossover, Vehicle-Controlled Clinical Trial. J Clin Aesthet Dermatol. 2024 Aug;17(8):19-26. |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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transepidermal water loss in g/m2/h |
| 4-weeks |
| Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. | stratum corneum water content (wt%) | 4-weeks |
| Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. | sebum production in µg/cm2 | 4-weeks |
| Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. | facial L*a*b* values | 4-weeks |