Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
- Conditions
- Papulopustular Rosacea
- Interventions
- Drug: Encapsulated Benzoyl Peroxide Cream
- Registration Number
- NCT05675501
- Lead Sponsor
- Sol-Gel Technologies, Ltd.
- Brief Summary
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:
* How the drug affects the skin microbiome compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.
* How the drug affects the skin physical properties compared with vehicle when applied once daily for 8 weeks in subjects with papulopustular rosacea.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
- Male and female 18 years of age and older.
- Participants must have clinical diagnosis of moderate to severe rosacea.
- Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
- Have 2 nodules or less.
- Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
- Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
- Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Study Drug Encapsulated Benzoyl Peroxide Cream 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), Vehicle Encapsulated Benzoyl Peroxide Cream 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),
- Primary Outcome Measures
Name Time Method Change in transepidermal water loss after 8-weeks of treatment compared to baseline. 8-weeks transepidermal water loss in g/m2/h
Change in stratum corneum hydration after 8-weeks of treatment compared to baseline. 8-weeks stratum corneum water content (wt%)
Change in colorimeter test after 8-weeks of treatment compared to baseline. 8-weeks facial L\*a\*b\* values
Change in skin microbiome diversity after 8-weeks of treatment compared to baseline 8-weeks Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.
Change in sebum excretion rate after 8-weeks of treatment compared to baseline. 8-weeks sebum production in µg/cm2
- Secondary Outcome Measures
Name Time Method Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. 4-weeks stratum corneum water content (wt%)
Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. 4-weeks sebum production in µg/cm2
Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline 4-weeks Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.
Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. 4-weeks transepidermal water loss in g/m2/h
Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. 4-weeks facial L\*a\*b\* values
Trial Locations
- Locations (1)
Integrative Skin Science and Research (ISSR)
🇺🇸Sacramento, California, United States