A Study of S5G4T-1 in the Treatment of Papularpustular Rosacea

• ClinicalTrials.gov Identifier: NCT03564119
• Recruitment Status: Completed
• First Posted: June 20, 2018
• Results First Posted: December 15, 2021
• Last Update Posted: December 15, 2021
• Sponsor: Sol-Gel Technologies, Ltd.
• Information provided by (Responsible Party): Sol-Gel Technologies, Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Papulopustular Rosacea	Drug: S5G4T-1; Drug: S5G4T-2	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 372 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: S5G4T-1; Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.	Drug: S5G4T-1; 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.	Drug: S5G4T-2; Once a day topical cream; Other Name: Vehicle cream

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 18 years of age and older.
3. Participants must have clinical diagnosis of moderate to severe rosacea.
4. Have a minimum total of 15 and a maximum of 70 total inflammatory lesions (papules and/or pustules) including those present on the nose.
5. Have 2 nodules or less.

Exclusion Criteria:

1. 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.
2. Presence of more than 2 facial nodules or any nodule greater than 1 centimeter (cm).
3. Current or past ocular rosacea (for example, conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical or systemic antibiotics.

Contacts and Locations

Locations

United States, New York

Sol-Gel

Rochester, New York, United States, 14623

Sponsors and Collaborators

Sol-Gel Technologies, Ltd.

  Study Documents (Full-Text)

Documents provided by Sol-Gel Technologies, Ltd.:

Study Protocol  [PDF] October 24, 2018

Statistical Analysis Plan  [PDF] May 2, 2019

More Information

• Responsible Party: Sol-Gel Technologies, Ltd.
• ClinicalTrials.gov Identifier: NCT03564119
• Other Study ID Numbers: SGT-54-02
• First Posted: June 20, 2018
• 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

Keywords provided by Sol-Gel Technologies, Ltd.:

papulopustular rosacea

Additional relevant MeSH terms:

Rosacea; Skin Diseases; Benzoyl Peroxide; Dermatologic Agents