Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 1:20 PM
Study NCT ID:
NCT01706250
Status:
COMPLETED
Last Update Posted:
2017-08-23
First Post:
2012-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™
Sponsor:
Stiefel, a GSK Company
Organization:
Study Overview
Official Title:
U0289-401: An Evaluator Blinded, 8 Week, Split-Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and PROACTIV in Subjects With Acne
Status:
COMPLETED
Status Verified Date:
2017-04
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:
One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a lack of understanding of the instructions for use, or product cost/availability. Whatever the reason, poor compliance translates to decreased efficacy and increased frustration on the part of the user.
The current study will evaluate and compare the efficacy and tolerability of 2 over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner.
The current study will evaluate and compare the efficacy and tolerability of 2 over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner.
Detailed Description:
Acne vulgaris is an extremely common dermatological disease that is found typically in adolescence and young adulthood. Acne vulgaris manifests with open and closed comedones (blackheads and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and trunk. Scarring can occur, particularly if the lesions are inflamed and deep, even in the absence of external manipulation (eg, picking and squeezing) of the skin.
Acne vulgaris can be treated with a variety of agents that are selected to address the pathogenic factors assumed to be responsible for the type and degree of manifested acne lesions. Monotherapy and combination therapy regimens are both useful. Topical agents are generally used as first-line therapy and include retinoids, antibiotic preparations (eg, erythromycin and clindamycin), benzoyl peroxide (BPO), alpha and beta hydroxy acids (eg, glycolic and salicylic acid preparations), and azelaic acid. Systemic therapies are initiated in patients with moderate to severe inflammatory acne that does not respond to topical therapy.
Benzoyl peroxide has antimicrobial and anti inflammatory properties and is often considered an important component of acne treatment. Benzoyl peroxide is frequently the first product that adolescents will use for acne because it can be purchased without a prescription in several different concentrations and formulations.
One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a lack of understanding of the instructions for use, or product cost/availability. Whatever the reason, poor compliance translates to decreased efficacy and increased frustration on the part of the user.
The current study will evaluate and compare the efficacy and tolerability of 2 common, over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam compared with PROACTIV(2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner.
This is a randomized, 2 center, evaluator-blinded, split-face efficacy and tolerability study of MAXCLARITYII and PROACTIV, 2 over-the-counter, topical benzoyl peroxide product lines, in subjects with acne. Approximately 40 subjects, aged from 16 to 29 years, inclusive, with mild facial acne vulgaris are expected to participate in the study. No more than 50% of the subjects at each site can be enrolled under the age of 20.
An expert grader (blinded evaluator) will complete counts of inflamed lesions (papules/pustules) and noninflamed lesions (open/closed comedones), the Investigator's Static Global Assessment (ISGA), and an assessment of tolerability of each side of the face at each study visit. Subjects will assess tolerability on each side of the face at each study visit and will complete a product acceptability and preference questionnaire at the end of the study.
The study duration will be 8 weeks (56 days) with visits at baseline (day 1), week 1m week 2, week 4 and week 8. Only the expert grader (evaluator) will be blinded to the study product assignments; subjects and study nurses/coordinator will not be blinded.
Acne vulgaris can be treated with a variety of agents that are selected to address the pathogenic factors assumed to be responsible for the type and degree of manifested acne lesions. Monotherapy and combination therapy regimens are both useful. Topical agents are generally used as first-line therapy and include retinoids, antibiotic preparations (eg, erythromycin and clindamycin), benzoyl peroxide (BPO), alpha and beta hydroxy acids (eg, glycolic and salicylic acid preparations), and azelaic acid. Systemic therapies are initiated in patients with moderate to severe inflammatory acne that does not respond to topical therapy.
Benzoyl peroxide has antimicrobial and anti inflammatory properties and is often considered an important component of acne treatment. Benzoyl peroxide is frequently the first product that adolescents will use for acne because it can be purchased without a prescription in several different concentrations and formulations.
One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a lack of understanding of the instructions for use, or product cost/availability. Whatever the reason, poor compliance translates to decreased efficacy and increased frustration on the part of the user.
The current study will evaluate and compare the efficacy and tolerability of 2 common, over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam compared with PROACTIV(2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner.
This is a randomized, 2 center, evaluator-blinded, split-face efficacy and tolerability study of MAXCLARITYII and PROACTIV, 2 over-the-counter, topical benzoyl peroxide product lines, in subjects with acne. Approximately 40 subjects, aged from 16 to 29 years, inclusive, with mild facial acne vulgaris are expected to participate in the study. No more than 50% of the subjects at each site can be enrolled under the age of 20.
An expert grader (blinded evaluator) will complete counts of inflamed lesions (papules/pustules) and noninflamed lesions (open/closed comedones), the Investigator's Static Global Assessment (ISGA), and an assessment of tolerability of each side of the face at each study visit. Subjects will assess tolerability on each side of the face at each study visit and will complete a product acceptability and preference questionnaire at the end of the study.
The study duration will be 8 weeks (56 days) with visits at baseline (day 1), week 1m week 2, week 4 and week 8. Only the expert grader (evaluator) will be blinded to the study product assignments; subjects and study nurses/coordinator will not be blinded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: