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

NCT06729450 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-13

No results posted yet for this study

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.

Conditions

  • Acne Vulgaris on the Face

Interventions

DEVICE

DispersinB Acne Cleanser

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

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • Kane Biotech Inc

    lead INDUSTRY

Principal Investigators

  • Prinicipal Investigator · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2026-10-31
Completion
2026-12-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06729450 on ClinicalTrials.gov