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.
Male or female subject aged 18 years or older, at screening visit.
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.
Subject with a symmetrical number of lesions on the whole face.
The subject is a female of childbearing potential is willing to undergo UPTs throughout the study.
Subject with acne types other than acne vulgaris.
Subject with dermal conditions on the face that may interfere with study assessments in the opinion of the investigator (tattoo, skin abrasion, eczema, sun burn, scars, large nevi, etc.).
Subject with excessive facial hair that would interfere with study assessments, as judged by the investigator.
Pregnant women (positive urine pregnancy test at screening or baseline) or women planning pregnancy during the study.
Single group
DispersinB Acne Cleanser
DeviceDispersinB Acne Cleanser, strength: 80 ug/g, topical gel
Success rate per half-face
Success rate per half-face on the Investigator's Global Assessment - Percent of subjects rated "Clear" and "Almost Clear" on a 5-point scale (0=clear; 4=severe)
Change in inflammatory and noninflammatory lesion count
Change in inflammatory and noninflammatory lesion count per half-face - change in lesion counts equals week 12 count minus baseline count
Local tolerability
Local tolerability parameters (erythema, scaling, dryness, and stinging/burning) will be evaluated per half-face - Worst post-baseline assessment rated on a 5-point scale (0=none; 4=strong)
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Kane Biotech Inc
Lead sponsor
University of Miami
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
