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Completed

NCT Number: NCT03448939

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

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.

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Key information

Conditions

Papulopustular Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sol-Gel

Tampa, Florida, 33607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S5G4T-1

Drug

Once a day topical cream

Other names: Encapsulated benzoyl peroxide (E-BPO) cream

S5G4T-2

Drug

Once a day topical cream

Other names: Vehicle cream

Primary outcomes

  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)".

  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 outcomes

  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 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.

Sponsors and collaborators

Lead sponsor

Sol-Gel Technologies, Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2018
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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