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Trial record 1 of 1 for:    SGT-65-04
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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 : Completed
First Posted : December 3, 2018
Results First Posted : December 1, 2021
Last Update Posted : December 16, 2021
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 participants 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, 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 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 21, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: S6G5T-3
Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks.
Drug: S6G5T-3
Once a day topical cream
Other Name: Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)

Placebo Comparator: S6G5T-8 Vehicle Cream
Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Drug: S6G5T-8
Once a day topical cream
Other Name: Vehicle




Primary Outcome Measures :
  1. Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline [ Time Frame: Baseline through Week 12 ]
    Percentage of participants in each treatment group achieving an acne severity IGA score of "clear (score=0)" or "almost clear (score=1)" and achieving an acne severity IGA score of at least 2 grades less than Baseline.

  2. Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12 [ Time Frame: Baseline, Week 12 ]
    Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an analysis of covariance (ANCOVA) with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.

  3. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12 [ Time Frame: Baseline, Week 12 ]
    Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.


Secondary Outcome Measures :
  1. Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12 [ Time Frame: Baseline, Week 12 ]
    Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

  2. Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12 [ Time Frame: Baseline, Week 12 ]
    Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.

  3. Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face) [ Time Frame: Baseline and Week 12 ]
    Percent of participants in each treatment group achieving at least a 4-point reduction on Item 1 (Pimple) of patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 1 of the questionnaire was to assess the pimples on the participant's face at their worst, in the 24 hours prior to administration on an 11-point numeric rating scale (NRS) ranging from 0 ("no pimples at all") to 10 ("pimples as bad as you can imagine").

  4. Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face [ Time Frame: Baseline and Week 12 ]
    Percent of participants in each treatment group achieving at least a 4-point reduction on Item 5 (Embarrassment) of the patient-reported evaluation of facial acne compared to Baseline. The Pre-Face is a 7-item questionnaire that assesses acne vulgaris-related signs, symptoms, and impacts. Item 5 of the questionnaire was to assess how embarrassed the participant felt because of the acne at their worst in the 24 hours prior to administration on an 11-point NRS ranging from 0 ("not embarrassed at all") to 10 ("extremely embarrassed").

  5. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8 [ Time Frame: Baseline, Week 8 ]
    Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

  6. Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8 [ Time Frame: Baseline, Week 8 ]
    Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.

  7. Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4 [ Time Frame: Baseline, Week 4 ]
    Non-inflammatory lesions were characterized by open comedones (blackheads) and closed comedones (whiteheads). Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. Negative least squares means values represent decrease from Baseline.

  8. Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4 [ Time Frame: Baseline, Week 4 ]
    Inflammatory lesions were characterized by papules, pustules, nodules, and cysts. Least squares means and standard deviations from an ANCOVA with factors of treatment group and analysis center and the respective Baseline lesion count as a covariate. For the inflammatory lesion count analysis, the interaction of treatment by analysis center was included in the model based on the conclusion from the pooling analysis. Negative least squares means values represent decrease from Baseline.



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. 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.

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


Locations
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United States, North Carolina
Dermatology Consulting Services
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Sol-Gel Technologies, Ltd.
  Study Documents (Full-Text)

Documents provided by Sol-Gel Technologies, Ltd.:
Study Protocol  [PDF] November 1, 2018
Statistical Analysis Plan  [PDF] November 26, 2019

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Responsible Party: Sol-Gel Technologies, Ltd.
ClinicalTrials.gov Identifier: NCT03761784    
Other Study ID Numbers: SGT-65-04
First Posted: December 3, 2018    Key Record Dates
Results First Posted: December 1, 2021
Last Update Posted: December 16, 2021
Last Verified: December 2021
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
Tretinoin
Benzoyl Peroxide
Dermatologic Agents
Antineoplastic Agents
Keratolytic Agents