Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Miami | OTHER |
Not provided
Not provided
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:
Researchers will compare each half-face:
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DispersinB Acne Cleanser | Device | DispersinB Acne Cleanser, strength: 80 ug/g, topical gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline to week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
Subject with a washout period for systemic treatment less than:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | 305-689-2646 | ped49@med.miami.edu |
| Name | Affiliation | Role |
|---|---|---|
| Prinicipal Investigator | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33124 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided