Phase 3 N=434 Randomized Double-blind Treatment

A Study of S6G5T3 in the Treatment of Acne Vulgaris

Acne Vulgaris

Bottom Line

View on ClinicalTrials.gov: NCT03761810 ↗

Enrolled (actual)

434

Serious AEs

0.5%

Results posted

Dec 2021

Primary outcome: Primary: Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline — 25.4; 14.7 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: S6G5T-3 (Drug); S6G5T-8 (Drug)
Age: Pediatric, Adult, Older Adult · 9+ yrs
Sex: All
Sponsor: Sol-Gel Technologies, Ltd.
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Achieving an IGA Score of Clear or Almost Clear and a Score ≥2 Grades Less Than Baseline	25.4; 14.7	—
PRIMARY Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12	-16.2; -14.1	—
PRIMARY Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12	-24.2; -17.4	—
SECONDARY Percent Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 12	-54.4; -41.5	—
SECONDARY Percent Change From Baseline in Inflammatory Lesion Counts on the Face at Week 12	-57.6; -50.8	—
SECONDARY Percentage of Participants Achieving at Least a 4-Point Reduction on Item 1 (Pimple) of the Patient-Reported Evaluation of Facial Acne (Pre-Face)	35.1; 27.2	—
SECONDARY Percentage of Participants Achieving at Least a 4-Point Reduction on Item 5 (Embarrassment) of the Pre-Face	33.9; 37.1	—
SECONDARY Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 8	-20.0; -12.8	—
SECONDARY Change From Baseline in Inflammatory Lesion Counts on the Face at Week 8	-14.0; -12.5	—
SECONDARY Change From Baseline in Non-Inflammatory Lesion Counts on the Face at Week 4	-14.6; -10.8	—
SECONDARY Change From Baseline in Inflammatory Lesion Counts on the Face at Week 4	-10.7; -10.1	—

Summary

To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12 weeks in participants with acne vulgaris.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03761810). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.