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OpenTrials
Completed

NCT Number: NCT05675501

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.

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Key information

Conditions

Papulopustular Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Integrative Skin Science and Research (ISSR)

Sacramento, California, 95815, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Encapsulated Benzoyl Peroxide Cream

Drug

Subjects will use a "pea-size" amount for each area of the face

Primary outcomes

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

    Time frame: 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.

    Time frame: 8-weeks

    transepidermal water loss in g/m2/h

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

    Time frame: 8-weeks

    stratum corneum water content (wt%)

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

    Time frame: 8-weeks

    sebum production in µg/cm2

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

    Time frame: 8-weeks

    facial L*a*b* values

Secondary outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 4-weeks

    facial L*a*b* values

Sponsors and collaborators

Lead sponsor

Sol-Gel Technologies, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 9, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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