Back to resultsA Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
Primary Purpose
Papulopustular Rosacea
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
S5G4T-1
S5G4T-2
Sponsored by
About this trial
This is an interventional treatment trial for Papulopustular Rosacea focused on measuring papulopustular rosacea
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Sol-Gel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
S5G4T-1
S5G4T-2 Vehicle Cream
Arm Description
Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.
Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at 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
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.
Secondary Outcome Measures
Percent Change From Baseline in Inflammatory Lesion Counts at 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.
Full Information
NCT ID
NCT03564119
First Posted
June 10, 2018
Last Updated
December 13, 2021
Sponsor
Sol-Gel Technologies, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03564119
Brief Title
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
Official Title
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
June 10, 2019 (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 efficacy and safety of S5G4T-1 compared to S5G4T-1 vehicle when applied once daily for 12 weeks in participants with papulopustular rosacea.
Detailed Description
In this Phase 3, double-blind, randomized, vehicle-controlled, parallel-group pivotal study, participants will be admitted only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female participants at least 18 years of age with moderate or severe papulopustular rosacea will be eligible for enrollment for daily treatment with S5G4T-1 or its vehicle for 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papulopustular Rosacea
Keywords
papulopustular rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
372 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S5G4T-1
Arm Type
Experimental
Arm Description
Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.
Arm Title
S5G4T-2 Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
S5G4T-1
Other Intervention Name(s)
Encapsulated benzoyl peroxide (E-BPO) cream
Intervention Description
Once a day topical cream
Intervention Type
Drug
Intervention Name(s)
S5G4T-2
Other Intervention Name(s)
Vehicle cream
Intervention Description
Once a day topical cream
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear From Baseline at Week 12
Description
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.
Time Frame
Baseline through Week 12
Title
Change From Baseline in Inflammatory Lesion Counts at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
Description
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.
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Facility Information:
Facility Name
Sol-Gel
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea
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