NCT06729450

Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris

Split-face Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Kane Biotech Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center study using intra-individual comparison (right half-face versus left half-face) to evaluate the efficacy and tolerability of DispersinB Acne Cleanser for treatment of acne in adults. An initial sample size of 24 subjects is planned to be randomized in order to provide proof of concept efficacy and tolerability of the product. The main questions it aims to answer are: 1. Percent of subjects rated "Clear" and "Almost Clear" on a 5-point scale 0=clear; 4=severe) at 12 weeks 2. Change in inflammatory and noninflammatory lesion count per half-face at 12 weeks Researchers will compare each half-face: * one half facial wash with DispersinB Acne Cleanser and 4% Benzoyl Peroxide. * one half facial wash with 4% Benzoyl Peroxide only Subjects will use the DispersinB Acne Cleanser on the assigned facial side for 5 minutes and then will use the provided 4% Benzoyl peroxide facial wash to wash entire face for daily (evening) use.

Detailed description

This is a single-center study using intra-individual comparison (right half-face versus left half-face) to evaluate the efficacy and tolerability of DispersinB Acne Cleanser for treatment of acne. An initial sample size of 24 subjects is planned to be randomized in order to provide proof of concept efficacy and tolerability of the product. Subject eligibility is evaluated over a 28-day screening period. Qualified subjects will complete baseline assessments and be randomized (left face versus right face) to apply DispersinB Acne Cleanser over at 12-week treatment period, for an intra-individual, split-face comparison. Subjects will use the DispersinB Acne Cleanser on the assigned facial side for 5 minutes and then will use the provided 4% Benzoyl peroxide facial wash to wash entire face for daily (evening) use. Subjects who do not require a washout period may complete the Screening and Baseline visit/assessments on the same day. Subjects who initially fail screening may be re-screened once. Subjects will return to the clinic for efficacy and tolerability assessments at weeks 2, 4, 8, and 12. Study procedures and assessments are performed according to the schedule of activities, Section 1.3.

Conditions

• Acne Vulgaris on the Face

Interventions

Type	Name	Description
DEVICE	DispersinB Acne Cleanser	DispersinB Acne Cleanser, strength: 80 ug/g, topical gel

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-10-31
• Completion: 2026-12-16
• First posted: 2024-12-11
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study