Split-face Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris
Kane Biotech Inc
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.
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-individua…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subject aged 18 years or older, at screening visit. 2. Subject with clinical diagnosis of acne vulgaris on the face as defined by Investigator's Global Assessment (IGA) score of 2 (Mild) or 3 (Moderate), with the same score on both sides of the face. 3. Subject with a symmetrical number of lesions on the whole face. 4. The subject is a female of childbearing potential is willing to undergo UPTs throughout the study. 5. Subject having read, understood, and signed the approved Informed Consent Form (ICF) prior to any participation in the study. 6. Subject a…
Interventions
- DeviceDispersinB Acne Cleanser
DispersinB Acne Cleanser, strength: 80 ug/g, topical gel
Location
- University of MiamiMiami, Florida