Papulopustular RosaceaPhase 1NCT05675501
Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
A Phase 1 study testing Encapsulated Benzoyl Peroxide Cream in people with Papulopustular Rosacea, run by Sol-Gel Technologies, Ltd. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papulopustular Rosacea
- What is being tested?
- Encapsulated Benzoyl Peroxide Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 15 Jul 2021
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Integrative Skin Science and Research (ISSR)
Sacramento, California, 95815
About this study
Official title: Randomized, Double-Blind, Cross-Over, Vehicle Controlled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
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.
- Conditions
- Papulopustular Rosacea
- Being tested
- Encapsulated Benzoyl Peroxide Cream
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsulated Benzoyl Peroxide CreamDrug
Subjects will use a "pea-size" amount for each area of the face
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Experimental | 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), Receives: Drug: Encapsulated Benzoyl Peroxide Cream |
| Vehicle | Placebo comparator | 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), Receives: Drug: Encapsulated Benzoyl Peroxide Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8-weeks
Change in transepidermal water loss after 8-weeks of treatment compared to baseline.
transepidermal water loss in g/m2/h
Measured: 8-weeks
Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.
stratum corneum water content (wt%)
Measured: 8-weeks
Change in sebum excretion rate after 8-weeks of treatment compared to baseline.
sebum production in µg/cm2
Measured: 8-weeks
Change in colorimeter test after 8-weeks of treatment compared to baseline.
facial L*a*b* values
Measured: 8-weeks
Secondary outcomes (5)
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.
Measured: 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
Measured: 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%)
Measured: 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
Measured: 4-weeks
Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
facial L*a*b* values
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start10 Jun 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Papulopustular RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sol-Gel Technologies, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675501
- Sponsor's protocol ID
- SGT-54-08
- Status last verified
- Apr 2023
- First submitted
- 1 Dec 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Nong Y, Sugarman J, York JP, Levy-Hacham O, Nadora D, Mizrahi R, Galati A, Gallo RL, Sivamani RK. Effect of Topical Microencapsulated Benzoyl Peroxide on the Skin Microbiome in Rosacea: A Randomized, Double-Blind, Crossover, Vehicle-Controlled Clinical Trial. J Clin Aesthet Dermatol. 2024 Aug;17(8):19-26.
PubMed 39148964