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

Acne Vulgaris Clinical Trial

Official title:

A Phase 1b, Multicenter, Open-Label, Parallel-Group, Maximal Use Systemic Exposure (MUSE) Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3 Compared to Retin-A® 0.1% in Subjects With Moderate to Severe Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059523
• Other study ID #: SGT-65-03
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2019
• Est. completion date: February 6, 2020

Study information

• Verified date: March 2020
• Source: Sol-Gel Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: February 6, 2020
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• S6G5T-3
once daily
• Retin-A® 0.1% Cream
once daily

Locations

Country	Name	City	State
United States	DermResearch, Inc.	Austin	Texas
United States	J&S Studies, Inc	College Station	Texas

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	Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration	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	14 days