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A Study of S6G5T3 in the Treatment of Acne Vulgaris

NCT ID: NCT03761810

Last Updated: 2021-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

434 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2019-10-23

Brief Summary

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To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

Detailed Description

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In this Phase 3, multi-center, 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 9 years of age with facial acne vulgaris will be eligible for enrollment for daily treatment with S6G5T-3 or its vehicle S6G5T-8, for 12 weeks.

Conditions

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Acne Vulgaris

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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S6G5T-3

Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks

Group Type EXPERIMENTAL

S6G5T-3

Intervention Type DRUG

Once a day topical cream

S6G5T-8 Vehicle Cream

Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.

Group Type PLACEBO_COMPARATOR

S6G5T-8

Intervention Type DRUG

Once a day topical cream

Interventions

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S6G5T-3

Once a day topical cream

Intervention Type DRUG

S6G5T-8

Once a day topical cream

Intervention Type DRUG

Other Intervention Names

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Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream) Vehicle

Eligibility Criteria

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Inclusion Criteria

1. Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study.
2. Male and female 9 years of age and older.
3. Have 2 or fewer cysts or nodules.

Exclusion Criteria

1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter \[mm\] in diameter).
2. Acne conglobata, acne fulminans and secondary acne (for example, chloracne, drug-induced acne).
3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma).
4. Underlying disease that requires the use of interfering topical or systemic therapy.
5. Other dermatological conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments such as, but not limited to, atopic dermatitis, perioral dermatitis, or rosacea.
Minimum Eligible Age

9 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 site 501

Tampa, Florida, United States

Site Status

Countries

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United States

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-65-05

Identifier Type: -

Identifier Source: org_study_id