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

Primary Purpose

Papulopustular Rosacea

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Encapsulated Benzoyl Peroxide Cream
Sponsored by
Sol-Gel Technologies, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Papulopustular Rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Integrative Skin Science and Research (ISSR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study Drug

Vehicle

Arm Description

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),

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),

Outcomes

Primary Outcome Measures

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.
Change in transepidermal water loss after 8-weeks of treatment compared to baseline.
transepidermal water loss in g/m2/h
Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.
stratum corneum water content (wt%)
Change in sebum excretion rate after 8-weeks of treatment compared to baseline.
sebum production in µg/cm2
Change in colorimeter test after 8-weeks of treatment compared to baseline.
facial L*a*b* values

Secondary Outcome Measures

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.
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
Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
stratum corneum water content (wt%)
Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
sebum production in µg/cm2
Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
facial L*a*b* values

Full Information

First Posted
December 1, 2022
Last Updated
April 16, 2023
Sponsor
Sol-Gel Technologies, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05675501
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sol-Gel Technologies, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Drug
Arm Type
Experimental
Arm Description
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),
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
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),
Intervention Type
Drug
Intervention Name(s)
Encapsulated Benzoyl Peroxide Cream
Intervention Description
Subjects will use a "pea-size" amount for each area of the face
Primary Outcome Measure Information:
Title
Change in skin microbiome diversity after 8-weeks of treatment compared to baseline
Description
Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.
Time Frame
8-weeks
Title
Change in transepidermal water loss after 8-weeks of treatment compared to baseline.
Description
transepidermal water loss in g/m2/h
Time Frame
8-weeks
Title
Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.
Description
stratum corneum water content (wt%)
Time Frame
8-weeks
Title
Change in sebum excretion rate after 8-weeks of treatment compared to baseline.
Description
sebum production in µg/cm2
Time Frame
8-weeks
Title
Change in colorimeter test after 8-weeks of treatment compared to baseline.
Description
facial L*a*b* values
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline
Description
Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.
Time Frame
4-weeks
Title
Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
Description
transepidermal water loss in g/m2/h
Time Frame
4-weeks
Title
Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
Description
stratum corneum water content (wt%)
Time Frame
4-weeks
Title
Change in sebum excretion rate after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
Description
sebum production in µg/cm2
Time Frame
4-weeks
Title
Change in colorimeter test after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
Description
facial L*a*b* values
Time Frame
4-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Integrative Skin Science and Research (ISSR)
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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