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

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: S6G5T-3; Drug: Retin-A® 0.1% Cream

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: S6G5T-3; topical cream	Drug: S6G5T-3; once daily
ACTIVE_COMPARATOR: Retin-A® 0.1% Cream; topical cream	Drug: Retin-A® 0.1% Cream; once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sol-Gel Technologies, Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 27, 2019
• Primary Completion (ACTUAL): February 6, 2020
• Study Completion (ACTUAL): February 6, 2020

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (ACTUAL): August 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Antineoplastic Agents; Dermatologic Agents; Keratolytic Agents; Tretinoin
• Other Study ID Numbers: SGT-65-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No