A Phase 1 interventional study of Encapsulated Benzoyl Peroxide Cream in Papulopustular Rosacea, sponsored by Sol-Gel Technologies, Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Sol-Gel Technologies, Ltd. · Phase 1, Interventional, and Other
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:
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 31 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Sol-Gel Technologies, Ltd. is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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),
Drug: Encapsulated Benzoyl Peroxide Cream
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),
Drug: Encapsulated Benzoyl Peroxide Cream
Subjects will use a "pea-size" amount for each area of the face
Change in skin microbiome diversity after 8-weeks of treatment compared to baseline
Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.
Time frame: 8-weeks
Change in transepidermal water loss after 8-weeks of treatment compared to baseline.
transepidermal water loss in g/m2/h
Time frame: 8-weeks
Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.
stratum corneum water content (wt%)
Time frame: 8-weeks
Change in sebum excretion rate after 8-weeks of treatment compared to baseline.
sebum production in µg/cm2
Time frame: 8-weeks
Change in colorimeter test after 8-weeks of treatment compared to baseline.
facial L\*a\*b\* values
Time frame: 8-weeks
Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline
Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.
Time frame: 4-weeks
Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
transepidermal water loss in g/m2/h
Time frame: 4-weeks
Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
stratum corneum water content (wt%)
Time frame: 4-weeks
Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
sebum production in µg/cm2
Time frame: 4-weeks
Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
facial L\*a\*b\* values
Time frame: 4-weeks
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sol-Gel Technologies, Ltd.