Acne Vulgaris on the FaceNCT06729450
Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris
A study testing DispersinB Acne Cleanser in people with Acne Vulgaris on the Face, run by Kane Biotech Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris on the Face
- What is being tested?
- DispersinB Acne Cleanser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to 16 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 27Show fewer
- 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
- Oral retinoids/isotretinoin - 12 weeks
- Cyproterone acetate/Chlomadinone acetate - 12 weeks
- Immunomodulators - 12 weeks
- Subject is currently receiving any prescription testosterone therapy or on a testosterone booster or supplements.
- The subject is unwilling or unable to refrain from use of prohibited medication or procedures during the study.
- Subject who will experience intensive ultraviolet exposure during the study (sunbathing, tanning beds, etc.).
- Subject with an acute/chronic disease or a history of major medical, surgical, or psychiatric condition or surgical interventions that may interfere with the interpretation of the study results.
- Study site personnel or employees/close relatives of the study Sponsor.
- Subject who has participated in another investigational treatment study within 30 days prior to screening.
- Subject with a history of alcohol/drug abuse.
- Subject who is unable to communicate or cooperate with the investigator due to language problems or impaired cognitive/verbal function.
- Subject is currently incarcerated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Miami
Miami, Florida, 33124
Kane Prinicipal Investigator, 1305-243-1000, ped49@med.miami.edu
About this study
Official title: Split-face Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris
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:
Read more
- Percent of subjects rated "Clear" and "Almost Clear" on a 5-point scale 0=clear; 4=severe) at 12 weeks
- 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.
Read the detailed 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-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.
Subjects who do not require a washout period may complete the Screening and Baseline visit/assessments on the same day. Subjects who initially fail screening may be re-screened once.
Subjects will return to the clinic for efficacy and tolerability assessments at weeks 2, 4, 8, and 12. Study procedures and assessments are performed according to the schedule of activities, Section 1.3.
- Conditions
- Acne Vulgaris on the Face
- Being tested
- DispersinB Acne Cleanser
- Keywords
- acne, dermatosis
- Medical subject headings
- Acne Vulgaris, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DispersinB Acne CleanserDevice
DispersinB Acne Cleanser, strength: 80 ug/g, topical gel
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: DispersinB Acne Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: baseline to week 12
Secondary outcomes (1)
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)
Measured: baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start30 Jan 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Vulgaris on the FaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kane Biotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Responsible party
- Sponsor
- Investigators
- Prinicipal Investigator, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06729450
- Sponsor's protocol ID
- DB-A001
- Status last verified
- May 2025
- First submitted
- 5 Dec 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split-face Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris
- ClinicalTrials.gov ID
- NCT06729450
- Acronym / sponsor ID
- DB-A001
- Conditions
- Acne Vulgaris on the Face
- Keywords
- acne, dermatosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Kane Biotech IncIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Percent of subjects rated "Clear" and "Almost Clear" on a 5-point scale 0=clear; 4=severe) at 12 weeks
- 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.
Detailed 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-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.
Subjects who do not require a washout period may complete the Screening and Baseline visit/assessments on the same day. Subjects who initially fail screening may be re-screened once.
Subjects will return to the clinic for efficacy and tolerability assessments at weeks 2, 4, 8, and 12. Study procedures and assessments are performed according to the schedule of activities, Section 1.3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intra-individual Split-face comparison | Experimental | Device: DispersinB Acne CleanserSubjects 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (27 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DispersinB Acne CleanserDispersinB Acne Cleanser, strength: 80 ug/g, topical gel | Device | intra-individual Split-face comparison |
Primary outcome
Success rate per half-face
Time frame: Baseline to week 12
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
Time frame: baseline to week 12
Change in inflammatory and noninflammatory lesion count per half-face - change in lesion counts equals week 12 count minus baseline count
1 secondary outcome
Local tolerability
Time frame: baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prinicipal Investigator principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DispersinB Acne Cleanser in people with Acne Vulgaris on the Face, run by Kane Biotech Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (305-689-2646, ped49@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate per half-face (time frame: Baseline to week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.