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

• Status: Completed
• Trial end date: 2021-07-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sol-Gel Technologies, Ltd.
• Treatments: Benzoyl Peroxide

Criteria

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.