Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
Study NCT ID:
NCT06729450
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-13
First Post:
2024-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris
Sponsor:
Kane Biotech Inc
Organization:
Study Overview
Official Title:
Split-face Efficacy and Tolerability of DispersinB Acne Cleanser in the Treatment of Mild to Moderate Acne Vulgaris
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: