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

NCT06729450 | Not Yet Recruiting FDA Device

• 1 other identifier: DB-A001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Acne Vulgaris on the Face

Keywords

acne; dermatosis

Outcome Measures

Primary Outcomes (2)

• 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)

  Baseline to week 12

• 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

  baseline to week 12

Secondary Outcomes (1)

• Local tolerability

  baseline to week 12

Study Arms (1)

intra-individual Split-face comparison

EXPERIMENTAL

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.

Device: DispersinB Acne Cleanser

Interventions

DispersinB Acne Cleanser DEVICE

DispersinB Acne Cleanser, strength: 80 ug/g, topical gel

intra-individual Split-face comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 having read, understood, and signed the approved Informed Consent Form (ICF) prior to any participation in the study.
• Subject agrees and is able to comply with all time commitments and procedural requirements of the protocol.
• Subject agrees to having facial photographs taken and verified by the subject signing an approved photography ICF.
• Subject is informed of terms pertaining to personal information protection and privacy and is willing to share personal information and data, as verified by signing a written authorization form.

You may not qualify if:

• 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.
• Subjects taking Vitamin A supplements in excess of the recommended daily allowance (4000-5000 IU; no washout period is required).
• Subject with a washout period for topical treatment or procedures on the face less than:
• Topical treatments: corticosteroids, antibiotics, azelaic acid, alpha hydroxy acids, salicylic acid, zinc containing treatments, hydroquinones, and other anti-acne treatments - 2 weeks
• Topical retinoids - 2 weeks
• Calascoterone cream 1% - 2 weeks
• Cosmetic/aesthetic procedures (e.g., comedo extraction, desquamating, or abrasive agents, adhesive "pore" cleansing strips) - 1 week
• Wax epilation - 2 weeks
• Photodynamic therapy - 4 weeks
• Laser therapy, microdermabrasion, deep chemical peel, and other plastic surgical treatments for acne - 12weeks
• Subject with a washout period for systemic treatment less than:
• Corticosteroids (except locally acting such as inhaled or intrathecal), antibiotics, and spironolactone - 4 weeks

Sponsors & Collaborators

• Kane Biotech Inc: lead
• University of Miami: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33124, United States

Location

MeSH Terms

Conditions

Acne Vulgaris; Skin Diseases

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Officials

• Prinicipal Investigator

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

305-689-2646; ped49@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: January 30, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)