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

NCT ID: NCT03564145

Last Updated: 2021-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

547 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-12

Study Completion Date

2019-11-13

Brief Summary

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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).

Detailed Description

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This is a long-term safety study for participants who completed either study SGT-54-01 or SGT-54-02. Participants will be admitted into the study only after a written informed consent has been obtained and not missing more than 1 visit of Visits 3, 4 or 5 in these studies. Eligible participants for enrollment will apply the study product, S5G4T-1, daily for up to an additional 40 weeks for a total of up to 52 weeks for some participants.

Conditions

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Papulopustular Rosacea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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S5G4T-1

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

Group Type EXPERIMENTAL

S5G4T-1

Intervention Type DRUG

Once a day topical cream

Interventions

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S5G4T-1

Once a day topical cream

Intervention Type DRUG

Other Intervention Names

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Encapsulated Benzoyl Peroxide (E-BPO) Cream

Eligibility Criteria

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Inclusion Criteria

1. Participants must sign an Institutional Review Board (IRB) approved written informed consent for the extension study.
2. 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.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sol-Gel Technologies, Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sol-Gel

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37636251 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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SGT-54-07

Identifier Type: -

Identifier Source: org_study_id