MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3

Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Retin-A® 0.1% Cream; Drug: S6G5T-3

• Registration Number: NCT04059523
• Lead Sponsor: Sol-Gel Technologies, Ltd.

Brief Summary

To assess the degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) Retin-A® 0.1% Cream when applied topically once daily for 14 days, under maximal use conditions in adolescents ≥12 years of age and adults with acne vulgaris.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-27
• Study First Submitted: 2019-08-01
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-16
• Primary Completion: 2020-02-06
• Study Completion: 2020-02-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Male and female subjects 9 years of age or older.
2. Subject must consent to participate, verified by signing an approved written Informed Consent Form (ICF).
3. Subjects must be generally healthy and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations
4. All females of child-bearing potential and premenarchal, excluding women who are surgically sterile

Exclusion Criteria

1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne etc.) or severe acne requiring systemic treatment.
2. Underlying disease which requires the use of topical or systemic therapy which may confound study results or make results difficult to interpret.;
3. Subjects unable to communicate well with the site study team (i.e., language problem, poor mental development or impaired cerebral function).
4. Any other factor that, in the opinion of the Investigator, would prevent the subject from complying with the requirements of the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retin-A® 0.1% Cream	Retin-A® 0.1% Cream	topical cream
S6G5T-3	S6G5T-3	topical cream

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration	14 days	The degree of systemic exposure of S6G5T-3 compared to the Reference Listed Drug (RLD) when applied topically once daily for 14 days, under maximal use conditions in subjects with acne vulgaris. Cmax = Maximum plasma concentration will be calculated

Trial Locations

Locations (2)

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

J&S Studies, Inc; 🇺🇸 College Station, Texas, United States