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

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

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 Overview

• Status: Completed
• Conditions: Papulopustular Rosacea
• Intervention / Treatment: Drug: Encapsulated Benzoyl Peroxide Cream

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
      • Integrative Skin Science and Research (ISSR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Drug; 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; Subjects will use a "pea-size" amount for each area of the face
Placebo Comparator: Vehicle; 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; Subjects will use a "pea-size" amount for each area of the face

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sol-Gel Technologies, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): July 15, 2021
• Study Completion (Actual): July 15, 2021

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Dermatologic Agents; Benzoyl Peroxide
• Other Study ID Numbers: SGT-54-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No