8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat 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 and compare the efficacy and tolerability of 2 over the counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5% benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam compared with MURAD Clarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion.

Detailed Description
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Acne vulgaris (acne) is an extremely common dermatological disease that is found typically in adolescence and young adulthood. Acne manifests with open and closed comedones (blackheads and whiteheads), papules, pustules, nodules, and cysts on the face, neck, and trunk. Acne 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 [SA] 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. Salicylic acid has comedolytic properties and is often used when other topical therapies are not tolerated. Benzoyl peroxide and SA are frequently the first products that adolescents will use for acne because both 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 over the counter, topical product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5% benzoyl peroxide [BPO]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam compared with MURADClarifying Cleanser (1.5% salicylic acid [SA]) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion. This is a randomized, single center, evaluator blinded, split face efficacy and tolerability study of MaxClarity II and Murad, 2 over the-counter, topical product lines for the treatment of acne. Approximately 20 subjects, aged from 16 to 29 years, inclusive, with mild facial acne 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 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 1, week 2, week 4 and week 8. Only the expert grader (evaluator) will be blinded to the study product assignments; subjects and study nurses/coordinators will not be blinded.

Official Title
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U0289-404: An Evaluator Blinded, 8 Week, Split Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITYII and MURAD in Subjects With Acne

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: MAXCLARITY II (2.5% BPO) Foam Cleanser
* Other: MAXCLARITY II (2.5% BPO) Foam Treatment
* Other: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam
* Other: MURAD Clarifying Cleanser (1.5% SA)
* Other: Exfoliating Acne Treatment Gel (1% SA)
* Other: Skin Perfecting Lotion


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, characterized by at least 12 facial inflammatory lesions (papules and pustules) and/or noninflammatory lesions (open and closed comedones) on each half of the face (excluding nose and front hairline areas). 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 an active or chronic skin allergy. 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. 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. 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAXCLARITY II<br>MAXCLARITY II Foam Cleanser (2.5% BPO) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam. Available over the counter. Each subject applies both arms (MAXCLARITY II and MURAD) simultaneously for the entire duration of the study (8 weeks), each arm to be applied to one side of the face only (split-face study) according to randomization. | Other: MAXCLARITY II (2.5% BPO) Foam Cleanser<br>* Available over the counter.<br>Other: MAXCLARITY II (2.5% BPO) Foam Treatment<br>* Available over the counter.<br>Other: MAXCLARITY II (0.5% Salicylic Acid) Toner Foam<br>* Available over the counter.<br>|
| Active Comparator: MURAD<br>MURADClarifying Cleanser (1.5% SA) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion. Available over the counter. Each subject applies both arms (MAXCLARITY II and MURAD) simultaneously for the entire duration of the study (8 weeks), each arm to be applied to one side of the face only (split-face study) according to randomization. | Other: MURAD Clarifying Cleanser (1.5% SA)<br>* Available over the counter.<br>Other: Exfoliating Acne Treatment Gel (1% SA)<br>* Available over the counter.<br>Other: Skin Perfecting Lotion<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. | During each study visit, expert grader (blinded 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 [blackheads] and closed [whiteheads] comedones) 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 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 is defined as value at Day 1. | Baseline 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 Week 1, 2 and 4. | During each study visit, expert grader (blinded 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 were calculated as the sum of the inflammatory and non-inflammatory lesion counts. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1. | Baseline and Week 1, 2, 4 | 
| Mean Change in Investigator's Static Global Assessment (ISGA) From Baseline to Week 1, 2, 4 and 8 | During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1. | Baseline and Week 1, 2, 4, 8 | 
| Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8. | Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1. | Baseline 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 from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline. Baseline is defined as value at Day 1. | Baseline and Week 1, 2, 4, 8 | 
| Percentage of Participant Who Improved by at Least One Grade on the ISGA | During each study visit, investigators/expert grader evaluated the acne severity of participants' faces using the ISGA scale on right and left side of face on a five point scale from 0 to 4 defined as 0-clear, 1-almost clear, 2-mild, 3-moderate, 4-severe. Percent change from Baseline to scheduled time point was calculated as the value at scheduled time point minus the value at Baseline divided by the Baseline value multiplied by 100. Baseline is defined as value at Day 1. | Up to Week 8 |