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

Last updated: December 14, 2021
Sponsor: Sol-Gel Technologies, Ltd.
Overall Status: Completed

Phase

3

Condition

Acne

Rash

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03761784
SGT-65-04
  • Ages > 9
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than orequal 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 orsystemic therapy or that might interfere with study assessments such as, but notlimited to, atopic dermatitis, perioral dermatitis, or rosacea.

Study Design

Total Participants: 424
Study Start date:
December 21, 2018
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • Dermatology Consulting Services

    High Point, North Carolina 27262
    United States

    Site Not Available

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