A Study of S6G5T-3 in the Treatment of Acne Vulgaris

Sol-Gel Technologies

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: S6G5T-8; Drug: S6G5T-3

Study type: Interventional

Funder types: Industry

Identifiers

NCT03761784

SGT-65-04

Details and patient eligibility

About

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

Full description

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.

Enrollment: 424 patients

Sex: All

Ages: 9+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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424 participants in 2 patient groups, including a placebo group

S6G5T-3

Experimental group

Description:

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

Treatment:

Drug: S6G5T-3

S6G5T-8 Vehicle Cream

Placebo Comparator group

Description:

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

Treatment:

Drug: S6G5T-8