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

Sol-Gel Technologies

Status and phase: Completed; Phase 1

Conditions: Papulopustular Rosacea

Treatments: Drug: Encapsulated Benzoyl Peroxide Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT05675501

SGT-54-08

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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31 participants in 2 patient groups, including a placebo group

Study Drug

Experimental group

Description:

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),

Treatment:

Drug: Encapsulated Benzoyl Peroxide Cream

Vehicle

Placebo Comparator group

Description:

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),

Treatment:

Drug: Encapsulated Benzoyl Peroxide Cream