Status:
COMPLETED
A Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Lead Sponsor:
Sol-Gel Technologies, Ltd.
Conditions:
Papulopustular Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess the efficacy and safety of S5G4T-1 compared to its vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.
Detailed Description
In this Phase 3, double-blind, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion...
Eligibility Criteria
Inclusion
- Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
- Male and female 18 years of age and older.
- Participants must have clinical diagnosis of moderate to severe rosacea.
- Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
- Have 2 nodules or less.
Exclusion
- Females, who are pregnant, breastfeeding, or planning a pregnancy within the period of their study participation or were found to have positive pregnancy test at Baseline or screening visits.
- Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
- Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.
Key Trial Info
Start Date :
June 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2019
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT03448939
Start Date
June 18 2018
End Date
May 24 2019
Last Update
December 14 2021
Active Locations (1)
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1
Sol-Gel
Tampa, Florida, United States, 33607