Back to resultsMUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
S6G5T-3
Retin-A® 0.1% Cream
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
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.
Sites / Locations
- DermResearch, Inc.
- J&S Studies, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
S6G5T-3
Retin-A® 0.1% Cream
Arm Description
topical cream
topical cream
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04059523
First Posted
August 1, 2019
Last Updated
March 17, 2020
Sponsor
Sol-Gel Technologies, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04059523
Brief Title
MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
February 6, 2020 (Actual)
Study Completion Date
February 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sol-Gel Technologies, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S6G5T-3
Arm Type
Experimental
Arm Description
topical cream
Arm Title
Retin-A® 0.1% Cream
Arm Type
Active Comparator
Arm Description
topical cream
Intervention Type
Drug
Intervention Name(s)
S6G5T-3
Intervention Description
once daily
Intervention Type
Drug
Intervention Name(s)
Retin-A® 0.1% Cream
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Pharmacokinetics of S6G5T-3 as measured by the maximum observed plasma concentration
Description
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
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies, Inc
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3
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