A Long-Term Safety Study of S5G4T-1 in the Treatment of Papulopustular Rosacea

NCT03564145 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: SGT-54-07
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety of S5G4T-1 when applied once daily for up to 40 weeks in participants with papulopustular rosacea who completed either Study SGT-54-01 (NCT03448939) or Study SGT-54-02 (NCT03564119).

Conditions

Papulopustular Rosacea

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Abnormalities presented at Baseline were considered AEs if they reoccurred after resolution or worsen during the AE collection period. An SAE was defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, or an important medical event. A summary of all SAEs and Other AEs (non-serious) regardless of causality is located in 'Reported Adverse Events' Section.

  Baseline up to Week 52

Study Arms (1)

S5G4T-1

EXPERIMENTAL

Participants will topically apply S5G4T-1 cream, once daily to face for 40 weeks.

Drug: S5G4T-1

Interventions

S5G4T-1 DRUG

Once a day topical cream

Also known as: Encapsulated Benzoyl Peroxide (E-BPO) Cream

S5G4T-1

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 the extension study.
• Participants must complete 12 weeks or within the Week 12 window time (± 4 days) of the double-blind treatment period of Study SGT-54-01 or Study SGT-54-02 and missed not more than 1 visit of Visits 3, 4 or 5 in Study SGT-54-01 or Study SGT-54-02.

Sponsors & Collaborators

• Sol-Gel Technologies, Ltd.: lead

Study Sites (1)

Sol-Gel

Rochester, New York, 14623, United States

Location

Related Publications (1)

• Werschler WP, Sugarman J, Bhatia N, Baldwin H, Green LJ, Nov O, Ram V, Levy-Hacham O, Stein Gold L. Long-term Efficacy and Safety of Microencapsulated Benzoyl Peroxide Cream, 5%, in Rosacea: Results From an Extension of Two Phase III, Vehicle-controlled Trials. J Clin Aesthet Dermatol. 2023 Aug;16(8):27-33.

  PMID: 37636251 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2018
• First Posted: June 20, 2018
• Study Start: September 12, 2018
• Primary Completion: November 13, 2019
• Study Completion: November 13, 2019
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-12

Locations

US (1)