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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04059523

Enrollment

Registered

2019-08-16

Start date

2019-06-27

Completion date

2020-02-06

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

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.

Interventions

DRUGS6G5T-3

once daily

DRUGRetin-A® 0.1% Cream

once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

9 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026