U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne

Study Overview
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Brief Summary
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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 the efficacy and tolerability of MAXCLARITY II, an over the counter, topical benzoyl peroxide (BPO) product line, in subjects with acne.

Detailed Description
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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 the efficacy and tolerability of MAXCLARITY II, an over the counter, topical benzoyl peroxide (BPO) product line, in subjects with acne. This is a multi center, open label study to evaluate the efficacy and tolerability of MAXCLARITY II, an over the-counter, topical benzoyl peroxide product line, in subjects with acne. Approximately 30 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 will complete counts of inflamed lesions (papules/pustules) and noninflamed lesions (open/closed comedones), the ISGA, and an assessment of tolerability at each study visit. Subjects will assess tolerability 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 1, week 2, week 4 and week 8.

Official Title
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U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: MAXCLARITY II (2.5% BPO) Foam Cleanser
* Drug: MAXCLARITY II (2.5% BPO) Foam Treatment
* Drug: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed. Male or female aged from 16 to 29 years, inclusive, at time of consent. No more than 50% of the subjects at each site can be enrolled under the age of 20. Mild facial acne vulgaris, characterized by at least 24 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on the face. Able to complete the study and to comply with study instructions. Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Acceptable contraceptive methods include the following: Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed. Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth naturally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermatocide is acceptable. Women who are not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study. Exclusion Criteria: Female who is pregnant, trying to become pregnant, or breast feeding. Has active or chronic skin allergies. Has a history of acute or chronic disease that might interfere with or increase the risk of study participation. Had skin cancer treatment in preceding 12 months. Has damaged skin on facial areas (eg, sunburn, tattoo, or scar) Had any medical procedure (eg, laser resurfacing, chemical peel, or plastic surgery) on facial areas in preceding 12 months. Had any cosmetic procedure (eg, microdermabrasion) on facial areas within 8 weeks of the baseline visit. Has any dermatological disorder that in the opinion of the investigator may interfere with the accurate evaluation of the subject's facial appearance. Received any investigational drug or procedure within 28 days of the baseline visit or is scheduled to receive an investigational drug (other than the study products) or procedure during the study. Currently using any medication that in the opinion of the investigator may affect the evaluation of the study products or place the subject at undue risk (including but not limited to asthma medications, oral steroids, rifampin, anticonvulsants, and St John's wart). Has a history of known or suspected intolerance to any of the ingredients of the study products (ie, benzoyl peroxide). Considered unable or unlikely to attend the necessary visits. Live in the same household as currently enrolled subjects. Employee of the investigator, a contract research organization, or Stiefel Laboratories who is involved in the study, or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee involved in the study.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAXCLARITY II<br>MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam. Available over-the-counter. | Drug: MAXCLARITY II (2.5% BPO) Foam Cleanser<br>* Available over the counter.<br>Drug: MAXCLARITY II (2.5% BPO) Foam Treatment<br>* Available over the counter.<br>Drug: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam<br>* Available over the counter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Week 8 | Evaluator assessed the left and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open [blackheads] and closed [whiteheads] comedones) and total lesions (sum of inflammatory and non-inflammatory lesion) for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to Week 8 was calculated as the value at Week 8 minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value . | Baseline (Day 1) and Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in Inflammatory, Non Inflammatory, and Total Lesion Counts From Baseline to Weeks 1, 2, and 4 | Evaluator assessed the left side and right side of the face as inflammatory (papules [solid elevation of skin with no visible fluid] and pustules [small inflamed elevation of the skin that is filled with pus]) and non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) and total lesions for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face from hairline to the mandible (including forehead, cheeks, and chin). Total lesion counts was calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to specified time (Weeks 1, 2, and 4) point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value . | Baseline (Day 1) and Week 1, 2, 4 | 
| Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Weeks 1, 2, 4 and 8 | Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value . | Baseline (Day 1) and Week 1, 2, 4, 8 | 
| Percentage of Participants Who Improved by at Least One Grade on the ISGA | Evaluator assessed the acne severity of participants' faces using the ISGA scale on a five point scale which ranged from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to specified time point was calculated as the value at specified time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline was defined as Day 1 value . | Up to Week 8 | 
| Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8. | Erythema , dryness, and peeling, were evaluated independently by the investigator on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value . | Baseline (Day 1) and Week 1, 2, 4, 8 | 
| Change in Participant Assessment of Tolerability (Redness, Dryness, Burning, Itching and Scaling) From Baseline to Weeks 1, 2, 4 and 8 | Redness, dryness, burning, itching and scaling were evaluated independently by the participant on a five point scale ranged from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to specified time point (Weeks 1, 2, 4 and 8) was calculated as the value at specified time point minus the value at Baseline. Baseline was defined as Day 1 value . | Baseline (Day 1) and Week 1, 2, 4, 8 |