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
1 other identifier
interventional
62
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2019
Shorter than P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 27, 2019
CompletedFirst Submitted
Initial submission to the registry
August 1, 2019
CompletedFirst Posted
Study publicly available on registry
August 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2020
CompletedMarch 18, 2020
March 1, 2020
7 months
August 1, 2019
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
S6G5T-3
EXPERIMENTALtopical cream
Retin-A® 0.1% Cream
ACTIVE COMPARATORtopical cream
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
DermResearch, Inc.
Austin, Texas, 78759, United States
J&S Studies, Inc
College Station, Texas, 77845, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2019
First Posted
August 16, 2019
Study Start
June 27, 2019
Primary Completion
February 6, 2020
Study Completion
February 6, 2020
Last Updated
March 18, 2020
Record last verified: 2020-03