Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties

Study Overview
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Brief Summary
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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: 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.

Official Title
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Randomized, Double-Blind, Cross-Over, Vehicle Controlled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties

Conditions
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Papulopustular Rosacea

Intervention / Treatment
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* Drug: Encapsulated Benzoyl Peroxide Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Drug<br>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), | Drug: Encapsulated Benzoyl Peroxide Cream<br>* Subjects will use a pea-size amount for each area of the face<br>|
| Placebo Comparator: Vehicle<br>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), | Drug: Encapsulated Benzoyl Peroxide Cream<br>* Subjects will use a pea-size amount for each area of the face<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |