Status:
COMPLETED
A Study of S6G5T-3 in the Treatment of Acne Vulgaris
Lead Sponsor:
Sol-Gel Technologies, Ltd.
Conditions:
Acne Vulgaris
Eligibility:
All Genders
9+ years
Phase:
PHASE3
Brief Summary
To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in participants with acne vulgaris.
Detailed Description
In this Phase 3, multi-center, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and aft...
Eligibility Criteria
Inclusion
- Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study.
- Male and female 9 years of age and older.
- Have 2 or fewer cysts or nodules.
Exclusion
- More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter (mm) in diameter).
- Acne conglobata, acne fulminans, and secondary acne (for example, chloracne, drug-induced acne).
- History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).
- Underlying disease that requires the use of interfering topical or systemic therapy.
- Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT03761784
Start Date
December 21 2018
End Date
December 31 2019
Last Update
December 16 2021
Active Locations (1)
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1
Dermatology Consulting Services
High Point, North Carolina, United States, 27262