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

NCT03564119 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SGT-54-02
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

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.

Conditions

Papulopustular Rosacea

Keywords

papulopustular rosacea

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

  Baseline, Week 12

Study Arms (2)

S5G4T-1

EXPERIMENTAL

Participants will topically apply S5G4T-1 cream, once daily to face for 12 weeks.

Drug: S5G4T-1

S5G4T-2 Vehicle Cream

PLACEBO COMPARATOR

Participants will topically apply S5G4T-2 vehicle cream, once daily to face for 12 weeks.

Drug: S5G4T-2

Interventions

S5G4T-1 DRUG

Once a day topical cream

Also known as: Encapsulated benzoyl peroxide (E-BPO) cream

S5G4T-1

S5G4T-2 DRUG

Once a day topical cream

Also known as: Vehicle cream

S5G4T-2 Vehicle Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sol-Gel Technologies, Ltd.: lead

Study Sites (1)

Sol-Gel

Rochester, New York, 14623, United States

Location

Related Publications (1)

• Bhatia ND, Werschler WP, Baldwin H, Sugarman J, Green LJ, Levy-Hacham O, Nov O, Ram V, Stein Gold L. Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From Two Phase III, Randomized, Vehicle-Controlled Trials. J Clin Aesthet Dermatol. 2023 Aug;16(8):34-40.

  PMID: 37636253 DERIVED

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sol-Gel
• Organization: Sol-Gel Technologies, Ltd.

info@sol-gel.com

972-8-9313433

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: June 20, 2018
• Study Start: June 21, 2018
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-12

Locations

US (1)