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

NCT ID: NCT03564119

Last Updated: 2021-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-21

Study Completion Date

2019-06-10

Brief Summary

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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.

Detailed Description

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In this Phase 3, double-blind, randomized, 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.

Conditions

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Papulopustular Rosacea

Keywords

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papulopustular rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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S5G4T-1

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

Group Type EXPERIMENTAL

S5G4T-1

Intervention Type DRUG

Once a day topical cream

S5G4T-2 Vehicle Cream

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

Group Type PLACEBO_COMPARATOR

S5G4T-2

Intervention Type DRUG

Once a day topical cream

Interventions

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S5G4T-1

Once a day topical cream

Intervention Type DRUG

S5G4T-2

Once a day topical cream

Intervention Type DRUG

Other Intervention Names

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Encapsulated benzoyl peroxide (E-BPO) cream Vehicle cream

Eligibility Criteria

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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.
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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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.

Reference Type DERIVED
PMID: 37636253 (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-54-02

Identifier Type: -

Identifier Source: org_study_id