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

Sol-Gel Technologies, Ltd.361 enrolled

Overview

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.

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 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

361

Conditions

Papulopustular Rosacea

Interventions

S5G4T-1DRUG

Once a day topical cream

S5G4T-2DRUG

Once a day topical cream

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sol-Gel

Tampa, Florida, United States

Outcomes

Primary Outcomes

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)".

Time frame: Baseline through Week 12

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.

Time frame: Baseline, Week 12

Secondary Outcomes

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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