Clinical trial NCT05675501: Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
Official title: Randomized, Double-Blind, Cross-Over, Vehicle Controlled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Papulopustular Rosacea
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in skin microbiome diversity after 8-weeks of treatment compared to baseline
timeFrame: 8-weeks
measure: Change in transepidermal water loss after 8-weeks of treatment compared to baseline.
timeFrame: 8-weeks
measure: Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.
timeFrame: 8-weeks
measure: Change in sebum excretion rate after 8-weeks of treatment compared to baseline.
timeFrame: 8-weeks
measure: Change in colorimeter test after 8-weeks of treatment compared to baseline.
timeFrame: 8-weeks
Secondary outcomes:
measure: Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline
timeFrame: 4-weeks
measure: Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
timeFrame: 4-weeks
measure: Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
timeFrame: 4-weeks
measure: Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
timeFrame: 4-weeks
measure: Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Integrative Skin Science and Research (ISSR)
state: California
Study officials:
References: