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

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ClinicalTrials.gov Identifier: NCT03761784
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : July 10, 2019
Sponsor:
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)
Estimated Enrollment : 420 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03761784


Contacts
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Contact: Ofra Levy-Hacham, Ph.D 972-8-9313433 ofra.levy-hacham@sol-gel.com

Locations
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United States, North Carolina
Dermatology Consulting Services Recruiting
High Point, North Carolina, United States, 27262
Contact: Vicky Ellis    336-841-3865    dcs3@northstate.net   
Principal Investigator: Zoe D Draelos, MD         
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.

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Responsible Party: Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT03761784     History of Changes
Other Study ID Numbers: SGT-65-04
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: November 2018
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

Keywords provided by Sol-Gel Technologies, Ltd.:
Acne Vulgaris

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases