U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne

Study Overview
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Brief Summary
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This study is being conducted to obtain safety, efficacy, and satisfaction data on the combination of topical Benzoyl Peroxide (BPO) 2.5% and the topical keratolytic agent Salicylic Acid (SA) 0.5% in the treatment of moderate to severe acne. Subjects with moderate or severe acne will be asked to apply the commercially available, over-the-counter products Foam Deep Cleanser (2.5% BPO), Foam Advanced Acne Treatment (2.5% BPO), and Foam Rejuvenating Toner (0.5% SA) daily for 12 weeks. No control group or reference treatment will be included.

Detailed Description
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This open-label, multicenter, study is being conducted to obtain safety, efficacy, and satisfaction data on an Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%), which includes Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advanced Acne Treatment (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid), in the treatment of moderate to severe acne. Approximately 120 male or female subjects ages 12-35 years, inclusive, with moderate or severe acne as assessed by Investigator's Global Assessment (ISGA) and lesion counts are expected to be enrolled. Subjects will be instructed to use all 3 study products as part of a complete acne treatment system; no reference therapy or control group will be included. Subjects will be instructed to apply Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Advnced Acne Treatment (2.5% Benzoyl Peroxide) to the face each morning and Foam Deep Cleanser (2.5% Benzoyl Peroxide) and Foam Rejuvenating Toner (0.5% Salicylic Acid) each evening over an application period of 12 weeks.

Official Title
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An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, Salicylic Acid 0.5%) in Subjects With Acne

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Other: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%


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 ages 12 to 35 years, inclusive at time of consent. ISGA score of 3 or 4 at Baseline. Lesion counts meeting all of the following criteria: A: A minimum of 25 but not more than 50 facial inflammatory lesions (papules and pustules), excluding nasal lesions. B: A minimum of 20 but not more than 100 facial non-inflammatory lesions (open and closed comedones), excluding nasal lesions. C: No more than 3 facial nodular lesions (<5mm), with no cystic lesions. Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. Negative urine pregnancy test for females of childbearing potential. 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. Exclusion Criteria: Female who is pregnant, trying to become pregnant, or breast feeding. History of lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, polycystic ovary syndrome, hirsutism, or perioral dermatitis. (Subjects with Seborrheic dermatitis may be enrolled if the condition has been inactive for at least 1 year and/or it does not affect the face.) Use of topical antibiotics on the face within the past 2 weeks or of systemic antibiotics for acne treatment within the past 4 weeks. Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the possibility of augmented photosensitivity. Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable. Use of systemic retinoids (eg, isotretinoin) within the past 6 months. Treatment with estrogens, including oral, implanted, injected, and topical contraceptives, androgens, or anti-androgenic agents for 12 weeks or fewer immediately prior to study enrollment. Subjects that have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris. Male with facial hair that could interfere with study assessments. Use of topical anti-acne medications (eg, BPO, retinoids, azelaic acid, resorcinol, sulfur and derivatives, SA, alpha or beta hydroxy acids, antioxidants, anti-wrinkle, antimicrobials, glycolic acid, abradants) within the past 2 weeks. Use of superficial facial procedures, and natural/herbal products within the past 4 weeks. Concomitant use of medications that are reported to exacerbate acne as these may impact efficacy assessments. Facial procedure (eg, blue light, chemical or laser peel, microdermabrasion) performed by aesthetician, beautician, physician, nurse, or other practitioner within the past 8 weeks. facial skin cancer diagnosis in preceding 12 months. Require or desire excessive or prolonged exposure to ultraviolet light (eg, sunlight or tanning beds) during the study. Dermatological disorder that in the opinion of the investigator may interfere with the accurate evaluation of the subject's facial appearance. Any major illness within 4 weeks before study enrollment. Previous use of the study products. Use of any investigational drug or procedure within the past 4 weeks or currently participating in another clinical study. Known hypersensitivity or previous allergic reaction to any of the active components of the study product. Any other condition which, in the judgement of the investigator, would put the subject at unacceptable risk for participation in the study. Current drug or alcohol abuse. (Drug screening is not required.) Considered unable or unlikely to attend the necessary visits. Employee of the investigator, clinical research organization, Stiefel, a GSK company, or GlaxoSmithKline (GSK) who is involved in the study, or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee who is involved in the study.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 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: Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5%<br>open label - no comparator; only Acne system - benzoyl peroxide 2.5%, Salicylic Acid 0.5% | Other: acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%<br>* over the counter acne system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Changes in Inflammatory (IL), Non-inflammatory (NIL), and Total Lesion (TL) Counts From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extended from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. Mean percent change from baseline at each study visit was presented. | Baseline (Day 1) and Week 1, 2, 4, 8, 12 | 
| Number of Participants With a Minimum 2-grade Improvement of Investigator's Static Global Assessment (ISGA) From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. | Baseline (Day 1) and Week 1, 2, 4, 8, 12 | 
| Number of Participants With ISGA Score of 0 (Clear) or 1 (Almost Clear) at Each Study Visit | The investigator assessed efficacy at baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). | Week 1, 2, 4, 8 and 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in IL, NIL, and TL Count From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by lesion counts- IL (papules and pustules), NIL (open and closed comedones), and TL. The area considered for efficacy assessments was confined to the face. The area of the face to be examined extends from the hairline to the mandible; includes the forehead, cheeks, and chin; and excludes the mouth, nasal region, periocular area, and superior and inferior eyelids. Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. | Baseline (Day 1) and Week 1, 2, 4, 8, 12 | 
| Mean Change in ISGA From Baseline to Each Study Visit | The investigator assessed efficacy at Baseline (Day 1), Week 1, 2, 4, 8 and 12 by ISGA scale: 0- Clear (clear skin with IL or NIL), 1- Almost clear (Rare NIL with no more than rare papules), 2- Mild (greater than Grade 1, some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3- Moderate (greater than Grade 2, up to many NIL and may have some IL, but no more than one small nodular lesion), 4- Severe (greater than Grade 3, up to many NIL and IL, but no more than a few nodular lesions) and 5- Very severe (Many NIL and IL and more than a few nodular lesions. May have cystic lesions). Baseline was defined at Day 1. Change from Baseline is value at indicated time point minus the Baseline value. | Baseline (Day 1) and Week 1, 2, 4, 8, 12 |