search
Back to results

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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
S6G5T-3
S6G5T-8
Sponsored by
Sol-Gel Technologies, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dermatology Consulting Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S6G5T-3

S6G5T-8 Vehicle Cream

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
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.
Change From Baseline in Inflammatory Lesion Counts on the Face at 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.
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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

Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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.
Percent Change From Baseline in Inflammatory Lesion Counts on the Face at 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.
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
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").
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
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").
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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.
Change From Baseline in Inflammatory Lesion Counts on the Face at 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.
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at 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.
Change From Baseline in Inflammatory Lesion Counts on the Face at 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.

Full Information

First Posted
November 30, 2018
Last Updated
December 14, 2021
Sponsor
Sol-Gel Technologies, Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT03761784
Brief Title
A Study of S6G5T-3 in the Treatment of Acne Vulgaris
Official Title
A Phase 3 Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study of S6G5T-3 in the Treatment of Acne Vulgaris
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sol-Gel Technologies, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
424 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S6G5T-3
Arm Type
Experimental
Arm Description
Participants will topically apply S6G5T-3 cream, once daily to face for 12 weeks.
Arm Title
S6G5T-8 Vehicle Cream
Arm Type
Placebo Comparator
Arm Description
Participants will topically apply S6G5T-8 vehicle cream, once daily to face for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
S6G5T-3
Other Intervention Name(s)
Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)
Intervention Description
Once a day topical cream
Intervention Type
Drug
Intervention Name(s)
S6G5T-8
Other Intervention Name(s)
Vehicle
Intervention Description
Once a day topical cream
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
Description
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.
Time Frame
Baseline through Week 12
Title
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Description
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.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
Description
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").
Time Frame
Baseline and Week 12
Title
Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
Description
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").
Time Frame
Baseline and Week 12
Title
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
Description
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.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
Description
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.
Time Frame
Baseline, Week 8
Title
Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
Description
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.
Time Frame
Baseline, Week 4
Title
Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
Description
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.
Time Frame
Baseline, Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant must sign an Institutional Review Board (IRB) approved written informed consent for this study. Male and female 9 years of age and older. Have 2 or fewer cysts or nodules. Exclusion Criteria: More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or equal to 5 millimeter (mm) in diameter). Acne conglobata, acne fulminans, and secondary acne (for example, chloracne, drug-induced acne). History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia, multiple myeloma). Underlying disease that requires the use of interfering topical or systemic therapy. 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.
Facility Information:
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs