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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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