Status:
COMPLETED
MUSE Study to Evaluate the Pharmacokinetics, Safety and Tolerability of S6G5T-3
Lead Sponsor:
Sol-Gel Technologies, Ltd.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
9+ years
Phase:
PHASE1
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 adol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04059523
Start Date
June 27 2019
End Date
February 6 2020
Last Update
March 18 2020
Active Locations (2)
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1
DermResearch, Inc.
Austin, Texas, United States, 78759
2
J&S Studies, Inc
College Station, Texas, United States, 77845