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

• Sponsor: Sol-Gel Technologies, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05675501
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Papulopustular Rosacea	Drug: Encapsulated Benzoyl Peroxide Cream	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• Official Title: Randomized, Double-Blind, Cross-Over, Vehicle Controlled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
• Actual Study Start Date: Jun 10, 2020
• Actual Primary Completion Date: Jul 15, 2021
• Actual Study Completion Date: Jul 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Drug 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; Subjects will use a "pea-size" amount for each area of the face
Placebo Comparator: Vehicle 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

Outcome Measures

Primary Outcome Measures

1. Change in skin microbiome diversity after 8-weeks of treatment compared to baseline [8-weeks]

   Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.

2. Change in transepidermal water loss after 8-weeks of treatment compared to baseline. [8-weeks]

   transepidermal water loss in g/m2/h

3. Change in stratum corneum hydration after 8-weeks of treatment compared to baseline. [8-weeks]

   stratum corneum water content (wt%)

4. Change in sebum excretion rate after 8-weeks of treatment compared to baseline. [8-weeks]

   sebum production in µg/cm2

5. Change in colorimeter test after 8-weeks of treatment compared to baseline. [8-weeks]

   facial L*a*b* values

Secondary Outcome Measures

1. Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline [4-weeks]

   Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.

2. Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. [4-weeks]

   transepidermal water loss in g/m2/h

3. Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. [4-weeks]

   stratum corneum water content (wt%)

4. Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. [4-weeks]

   sebum production in µg/cm2

5. Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline. [4-weeks]

   facial L*a*b* values

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Integrative Skin Science and Research (ISSR)	Sacramento	California	United States	95815

Sponsors and Collaborators

• Sol-Gel Technologies, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT05675501
• Other Study ID Numbers: SGT-54-08
• First Posted: Jan 9, 2023
• Last Update Posted: Jan 9, 2023
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rosacea; Benzoyl Peroxide

Study Results

No Results Posted as of Jan 9, 2023