Clinical trial NCT03761810: A Study of S6G5T3 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Sol-Gel Technologies, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-03
Enrollment: 434
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline
timeFrame: Baseline through Week 12
measure: Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face
timeFrame: Baseline and Week 12
measure: Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Sol-Gel site 501
state: Florida
Study officials:
References: