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

• Sponsor: Sol-Gel Technologies, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04059523
• Collaborator: (none)
• Enrollment: 62
• Locations: 2
• Arms: 2
• Actual Duration (Months): 7.4
• Patients Per Site: 31
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: S6G5T-3; Drug: Retin-A® 0.1% Cream	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 27, 2019
• Actual Primary Completion Date: Feb 6, 2020
• Actual Study Completion Date: Feb 6, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DermResearch, Inc.	Austin	Texas	United States	78759
2	J&S Studies, Inc	College Station	Texas	United States	77845

Sponsors and Collaborators

• Sol-Gel Technologies, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT04059523
• Other Study ID Numbers: SGT-65-03
• First Posted: Aug 16, 2019
• Last Update Posted: Mar 18, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris; Tretinoin

Study Results

No Results Posted as of Mar 18, 2020