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A Study of S6G5T 3 in the Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03761810
Recruitment Status : Completed
First Posted : December 3, 2018
Last Update Posted : March 18, 2020
Information provided by (Responsible Party):
Sol-Gel Technologies, Ltd.

Brief Summary:
To assess the efficacy of S6G5T-3 compared to its Vehicle when applied once daily for 12 weeks in Patients with acne vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: S6G5T-3 Drug: S6G5T-8 Phase 3

Detailed Description:
In this Phase 3, double blind, vehicle-controlled study, patients will be admitted into this multi-center, double blind, randomized, vehicle controlled, parallel group pivotal study only after a written informed consent has been obtained and after all inclusion/exclusion criteria have been met. Male and female patients 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris
Actual Study Start Date : December 17, 2018
Actual Primary Completion Date : December 11, 2019
Actual Study Completion Date : December 11, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: S6G5T-3
topical cream
Drug: S6G5T-3
once a day topical cream

Placebo Comparator: S6G5T-8
topical cream
Drug: S6G5T-8
once a day topical cream

Primary Outcome Measures :
  1. Investigator's Global Assessment (IGA) [ Time Frame: Week 12 ]
    Proportion of patients with the primary measure of success "Clear" (0) or "Almost clear" (1) in the IGA relative to Baseline at Week 12

  2. Lesion Counts [ Time Frame: Week 12 ]
    Absolute change from Baseline for inflammatory and non-inflammatory lesion count on the face at Week 12

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient 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 two (2) or fewer cysts or nodules

Exclusion Criteria:

  1. More than two acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 mm in diameter).
  2. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
  3. History of blood dyscrasia (e.g., leukemia, haemophilia, sickle cell anemia, multiple myeloma, etc.)
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03761810

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United States, Florida
Sol-Gel site 501
Tampa, Florida, United States, 33607
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.
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Responsible Party: Sol-Gel Technologies, Ltd. Identifier: NCT03761810    
Other Study ID Numbers: SGT-65-05
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases