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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-27

Study Completion Date

2020-02-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S6G5T-3

topical cream

Group Type EXPERIMENTAL

S6G5T-3

Intervention Type DRUG

once daily

Retin-A® 0.1% Cream

topical cream

Group Type ACTIVE_COMPARATOR

Retin-A® 0.1% Cream

Intervention Type DRUG

once daily

Interventions

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S6G5T-3

once daily

Intervention Type DRUG

Retin-A® 0.1% Cream

once daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No