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

Papulopustular Rosacea Clinical Trial

Official title:

A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564119
• Other study ID #: SGT-54-02
• Status: Completed
• Phase: Phase 3
• Start date: June 21, 2018
• Est. completion date: June 10, 2019

Study information

• Verified date: December 2021
• Source: Sol-Gel Technologies, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 372
• Est. completion date: June 10, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• S5G4T-1
Once a day topical cream
• S5G4T-2
Once a day topical cream

Locations

Country	Name	City	State
United States	Sol-Gel	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Sol-Gel Technologies, Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline through Week 12
Primary	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.	Baseline, Week 12
Secondary	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.	Baseline, Week 12