CompletedPhase 1

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

United States31 participantsStarted 2020-06-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in skin microbiome diversity after 8-weeks of treatment compared to baseline

Timeframe: 8-weeks

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

Timeframe: 8-weeks

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

Timeframe: 8-weeks

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

Timeframe: 8-weeks

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

Timeframe: 8-weeks

Trial details

NCT IDNCT05675501

SponsorSol-Gel Technologies, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-15

View on ClinicalTrials.gov More Papulopustular Rosacea trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in skin microbiome diversity after 8-weeks of treatment compared to baseline

Timeframe: 8-weeks

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

Timeframe: 8-weeks

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

Timeframe: 8-weeks

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

Timeframe: 8-weeks

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

Timeframe: 8-weeks