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

Sol-Gel Technologies

Status and phase

Completed

Phase 1

Conditions

Acne Vulgaris

Treatments

Drug: S6G5T-3

Drug: Retin-A® 0.1% Cream

Study type

Interventional

Funder types

Industry

Identifiers

NCT04059523

SGT-65-03

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

9+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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