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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2021-07-15

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.

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Detailed Description

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Conditions

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Papulopustular Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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),

Group Type EXPERIMENTAL

Encapsulated Benzoyl Peroxide Cream

Intervention Type DRUG

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

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),

Group Type PLACEBO_COMPARATOR

Encapsulated Benzoyl Peroxide Cream

Intervention Type DRUG

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

Interventions

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Encapsulated Benzoyl Peroxide Cream

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

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No