A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
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|ClinicalTrials.gov Identifier: NCT03564119|
Recruitment Status : Completed
First Posted : June 20, 2018
Results First Posted : December 15, 2021
Last Update Posted : December 15, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Papulopustular Rosacea||Drug: S5G4T-1 Drug: S5G4T-2||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||372 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea|
|Actual Study Start Date :||June 21, 2018|
|Actual Primary Completion Date :||June 10, 2019|
|Actual Study Completion Date :||June 10, 2019|
Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.
Once a day topical cream
Other Name: Encapsulated benzoyl peroxide (E-BPO) cream
Placebo Comparator: S5G4T-2 Vehicle Cream
Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Once a day topical cream
Other Name: Vehicle cream
- Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12 [ Time Frame: Baseline through Week 12 ]Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)". Please note, the Percentage of Participants multiplied by the Overall Number of Participants Analyzed does not equal a whole number because missing efficacy data was based on estimation using the method of Markov Chain Monte Carlo (MCMC) imputation.
- Change From Baseline in Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline, Week 12 ]Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment, analysis center and treatment by analysis center interaction and the Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
- Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 [ Time Frame: Baseline, Week 12 ]Inflammatory lesions were characterized as papules and pustules. A papule was defined as a solid, elevated inflammatory lesion equal to or less than 5 mm in diameter. A pustule was defined as an elevated inflammatory lesion equal to or less than 5 mm in diameter and contains pus (yellow-white exudate). Least squares means and standard deviations from an ANCOVA with factors of treatment and analysis center and Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564119
|United States, New York|
|Rochester, New York, United States, 14623|
Documents provided by Sol-Gel Technologies, Ltd.:
|Responsible Party:||Sol-Gel Technologies, Ltd.|
|Other Study ID Numbers:||
|First Posted:||June 20, 2018 Key Record Dates|
|Results First Posted:||December 15, 2021|
|Last Update Posted:||December 15, 2021|
|Last Verified:||December 2021|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|