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

Sol-Gel Technologies, Ltd.31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Papulopustular Rosacea

Interventions

Encapsulated Benzoyl Peroxide CreamDRUG

Subjects will use a "pea-size" amount for each area of the face

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Integrative Skin Science and Research (ISSR)

Sacramento, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 8-weeks

Change in transepidermal water loss after 8-weeks of treatment compared to baseline.

transepidermal water loss in g/m2/h

Time frame: 8-weeks

Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.

stratum corneum water content (wt%)

Time frame: 8-weeks

Change in sebum excretion rate after 8-weeks of treatment compared to baseline.

sebum production in µg/cm2

Time frame: 8-weeks

Change in colorimeter test after 8-weeks of treatment compared to baseline.

facial L\*a\*b\* values

Time frame: 8-weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 4-weeks

Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.

Data from ClinicalTrials.gov

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