DispersinB Cleanser for Acne

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kane Biotech Inc

Must not be taking: Vitamin A, Testosterone

Disqualifiers: Pregnancy, Excessive facial hair, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

24 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

Yes, you may need to stop certain medications before joining the trial. There are specific 'washout' periods (time without taking certain medications) for various treatments, such as 2 weeks for topical treatments and up to 12 weeks for some systemic treatments like oral retinoids.

What data supports the effectiveness of the treatment DispersinB Acne Cleanser for acne?

While there is no direct data on DispersinB Acne Cleanser, similar treatments like benzoyl peroxide and retinoids have shown effectiveness in reducing acne by addressing multiple factors involved in acne formation. Combination therapies, which include these ingredients, have been shown to significantly reduce acne lesions and improve skin condition. ^{1 2 3 4 5}

How is the DispersinB Acne Cleanser treatment different from other acne treatments?

DispersinB Acne Cleanser is unique because it likely targets biofilms (protective layers formed by bacteria), which can make acne bacteria more resistant to treatment. This approach is different from traditional acne treatments that primarily focus on reducing oiliness or directly killing bacteria. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Prinicipal Investigator

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for adults with mild to moderate acne vulgaris. Participants will treat one side of their face with DispersinB Acne Cleanser and the other side with a standard treatment, allowing researchers to compare results directly on each person.

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants apply DispersinB Acne Cleanser and 4% Benzoyl Peroxide for a split-face comparison over a 12-week period

12 weeks

4 visits (in-person) at weeks 2, 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DispersinB Acne Cleanser

Trial Overview The study tests if DispersinB Acne Cleanser can improve acne when used alongside Benzoyl Peroxide compared to using Benzoyl Peroxide alone. It's an intra-individual comparison over 12 weeks, focusing on how many people achieve clear skin and the change in number of acne lesions.

Participant Groups

Group I: intra-individual Split-face comparison Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Kane Biotech Inc

Lead Sponsor

Trials

1

Recruited

20+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Rapid and efficacious fixed-combination monotherapy: desired results for the patient and improved adherence for the clinician. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Development of a new patient-reported outcome measure for facial acne: the Acne Symptom and Impact Scale (ASIS). [2014]

3. England pubmed.ncbi.nlm.nih.gov

Adherence to drug treatments and adjuvant barrier repair therapies are key factors for clinical improvement in mild to moderate acne: the ACTUO observational prospective multicenter cohort trial in 643 patients. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A Topical Combination Regimen of Benzoyl Peroxide and Retinol Moisturizer for Mild to Moderate Acne. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Accelerated Onset of Action and Increased Tolerability in Treating Acne With a Fixed-Dose Combination Gel. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

ACNE VULGARIS. EVALUATION OF A MEDICATED CLEANSING PAD. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of self-treatment of mild-to-moderate facial acne with a blue light treatment system. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of benzoyl peroxide 9.8% emollient foam on reduction of Propionibacterium acnes on the back using a short contact therapy approach. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

A Cohort Study Using a Facial Cleansing Brush With Acne Cleansing Brush Head and a Gel Cleanser in Subjects With Mild-to-Moderate Acne and Acne-Prone Skin [2020]

10. England pubmed.ncbi.nlm.nih.gov

Significant improvement in mild acne following a twice daily application for 6 weeks of an acidic cleansing product (pH 4). [2016]