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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05675501
Other study ID # SGT-54-08
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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