A Study of S6G5T3 in the Treatment of Acne Vulgaris

NCT03761810 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SGT-65-05
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline through Week 12

• 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. Negative least squares means values represent decrease from Baseline.

  Baseline, Week 12

• 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.

  Baseline, Week 12

Secondary Outcomes (8)

• Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12

  Baseline, Week 12

• Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12

  Baseline, Week 12

• Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)

  Baseline and Week 12

• Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face

  Baseline and Week 12

• Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8

  Baseline, Week 8

Study Arms (2)

S6G5T-3

EXPERIMENTAL

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

Drug: S6G5T-3

S6G5T-8 Vehicle Cream

PLACEBO COMPARATOR

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

Drug: S6G5T-8

Interventions

S6G5T-3 DRUG

Once a day topical cream

Also known as: Encapsulated Benzoyl Peroxide (E-BPO) and Encapsulated Tretinoin (E-ATRA) Cream, (E-BPO/E-ATRA Cream)

S6G5T-3

S6G5T-8 DRUG

Once a day topical cream

Also known as: Vehicle

S6G5T-8 Vehicle Cream

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sol-Gel Technologies, Ltd.: lead

Study Sites (1)

Sol-Gel site 501

Tampa, Florida, 33607, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Sol-Gel
• Organization: Sol-Gel Technologies, Ltd.

info@sol-gel.com

972-8-9313433

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 3, 2018
• Study Start: December 14, 2018
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: December 16, 2021
• Results First Posted: December 1, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)