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

Papulopustular Rosacea Clinical Trial

Official title:

Randomized, Double-Blind, Cross-Over, Vehicle Controlled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05675501
• Other study ID #: SGT-54-08
• Status: Completed
• Phase: Phase 1
• Start date: June 10, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: April 2023
• Source: Sol-Gel Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• Encapsulated Benzoyl Peroxide Cream
Subjects will use a "pea-size" amount for each area of the face

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research (ISSR)	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Sol-Gel Technologies, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8-weeks
Primary	Change in transepidermal water loss after 8-weeks of treatment compared to baseline.	transepidermal water loss in g/m2/h	8-weeks
Primary	Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.	stratum corneum water content (wt%)	8-weeks
Primary	Change in sebum excretion rate after 8-weeks of treatment compared to baseline.	sebum production in µg/cm2	8-weeks
Primary	Change in colorimeter test after 8-weeks of treatment compared to baseline.	facial L*a*b* values	8-weeks
Secondary	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.	4-weeks
Secondary	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	4-weeks
Secondary	Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.	stratum corneum water content (wt%)	4-weeks
Secondary	Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.	sebum production in µg/cm2	4-weeks
Secondary	Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.	facial L*a*b* values	4-weeks