Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne

Study Overview
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Brief Summary
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This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Detailed Description
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A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).

Official Title
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A Phase 3 Multicenter, Randomized, Double-Blind, Active And Vehicle-Controlled Study Of The Safety And Efficacy Of A Clindamycin / Benzoyl Peroxide Gel Versus Clindamycin Gel Versus Benzoyl Peroxide Gel Versus Vehicle Gel In Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: clindamycin / benzoyl peroxide gel
* Drug: clindamycin gel
* Drug: BPO gel
* Drug: vehicle gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 12 to 45 years of age, inclusive, and in good general health. Clinical diagnosis of acne vulgaris Females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. Have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. Have the ability to understand and sign a written informed consent form, which must be completed prior to study specific tasks being performed. Subjects under the legal age of consent in the state/province/country where the study is conducted must provide assent and have the written informed consent of a parent or guardian. Exclusion Criteria: Are pregnant or breast-feeding. Have a history or presence of other conditions that may increase the risk of the subject participating in the study and/or affect the evaluated outcomes. Used topical antibiotics on the face or used systemic antibiotics within the past 2 weeks. Used topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular, or intra-lesional steroids other than for facial acne is acceptable. Used systemic retinoids within the past 6 months or topical retinoids within the past 6 weeks. Received treatment with estrogens (including oral, implanted, injected and topical contraceptives), androgens, or anti-androgenic agents for 12 weeks or less immediately prior to starting study product. Subjects who have been treated with estrogens, as described above, androgens, or anti-androgenic agents for more than 12 consecutive weeks prior to start of study product are allowed to enroll as long as they do not expect to change dose, drug, or discontinue use during the study. Used topical anti-acne medications (eg, BPO, azelaic acid, resorcinol, salicylates, etc.) within the past 2 weeks. Used abradents or facial procedures, within the past 2 weeks. Use medications that may exacerbate acne. Have a known hypersensitivity or have had previous allergic reaction to any of the active components, lincomycin, or excipients of the study product. Used any investigational therapy within the past 4 weeks, or currently participating in another clinical study.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 45 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>clindamycin / benzoyl peroxide gel | Drug: clindamycin / benzoyl peroxide gel<br>* Once a day application to the face<br>|
| Active Comparator: 2<br>Clindamycin gel | Drug: clindamycin gel<br>* Once a day application to the face<br>|
| Active Comparator: 3<br>BPO gel | Drug: BPO gel<br>* Once a day application to the face<br>|
| Placebo Comparator: 4<br>vehicle gel | Drug: vehicle gel<br>* Once a day application to the face<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Improvement of at Least 2 Grades in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | During each study visit, investigators/assessors evaluated acne severity of the participants' faces using the ISGA scale: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L. | Baseline (Day 1) and Week 12 | 
| Mean Change From Baseline (BL) to Week 12 in Inflammatory Lesion Counts | During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules [small inflamed elevation of the skin that is filled with pus], papules [solid elevation of skin with no visible fluid], nodules [larger than papules with significant depth]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). Missing values were imputed using the last observation carried forward (LOCF) method. | Baseline (Day 1) and Week 12 | 
| Mean Change From Baseline to Week 12 in Non-inflammatory Lesion Counts | During each study visit, trained study personnel at every investigational center assessed the non-inflammatory (open comedones [blackheads] and closed comedones [whiteheads]) lesion counts for each participant. Each type of lesion was counted separately, and counts were taken from the face (including forehead, nose, cheeks, and chin). | Baseline (Day 1) and Week 12 | 
| Mean Change From Baseline to Week 12 in Total Lesion Counts | During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, cheeks, and chin). Total lesion counts were calculated as the sum of the inflammatory and non-inflammatory lesion counts. | Baseline (Day 1) and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Baseline to Week 12 in Lesion Counts (Total, Inflammatory, and Non-inflammatory) | During each study visit, trained study personnel at every investigational center assessed the inflammatory (pustules, papules, nodules) and non-inflammatory (open and closed comedones) lesion counts for each participant. Each type of lesion was counted separately; the lesion counts were taken from the face (including forehead, nose, 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 12 was calculated as the value at Week 12 minus the value at Baseline divided by the Baseline value * 100. | Baseline (Day 1) and Week 12 | 
| Number of Participants Who Had a Subject Global Assessment (SGA) Score of 0 or 1 at Week 12 | During each study visit, participants evaluated their facial acne (excluding the scalp) using the SGA scale: 0=free of acne, with only an occasional blackhead/whitehead; 1=several blackheads/whiteheads and small pimples, no tender deep-seated bumps/cysts; 2=several to many blackheads/whiteheads and small to medium-sized pimples, one deep-seated bump/cyst; 3=many blackheads/whiteheads, many medium- to large-sized pimples, few deep-seated bumps/cysts; 4=presence of blackheads/whiteheads, several to many medium- to large-sized pimples, deep-seated bumps/cysts dominate. | Week 12 | 
| Number of Participants Who Had an ISGA Score of 0 or 1 at Week 12 | During each study visit, investigators/assessors evaluated the acne severity of participants' faces using the ISGA scal: 0=clear skin with no lesions (L); 1=almost clear, rare non-inflammatory L; 2=mild, some non-inflammatory L with no more than a few inflammatory L, no nodular L; 3=moderate, many non-inflammatory L, may have some inflammatory L, but no more than 1 small nodular L; 4=severe, many non-inflammatory and inflammatory L, but no more than a few nodular L; 5=very severe, many non-inflammatory and inflammatory L, and more than a few nodular L. | Week 12 | 
| Mean Change From Baseline to Week 12 in Systolic and Diastolic Blood Pressure | Systolic and diastolic blood pressure were measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. | Baseline (Day 1) and Week 12 | 
| Mean Change From Baseline to Week 12 in Temperature | Temperature was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. | Baseline (Day 1) and Week 12 | 
| Mean Change From Baseline to Week 12 in Pulse Rate | Pulse rate was measured at Baseline and Week 12 (end of study). Mean change from Baseline was calculated as the mean value at Week 12 minus the mean value at Baseline. | Baseline (Day 1) and Week 12 | 
| Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Erythema, Dryness, and Peeling | Erythema (Er, redness), dryness (Dr), and peeling (Pn), were evaluated independently by the investigator as: 0 (absent)=no Er, Dr, or Pn; 1 (slight)=faint red/pink coloration (col.), barely perceptible Dr with no flakes or fissure, mild localized Pn; 2 (mild)=light red/pink col., perceptible Dr with no flakes/fissure, mild and diffuse Pn; 3 (moderate)=medium red col., easily noted Dr and flakes but no fissure; 4 (severe)=beet red col., Dr with flakes and fissure, prominent dense Pn. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the the value at Baseline. | Baseline; Weeks 2, 4, 8, and 12 | 
| Mean Change From Baseline to Weeks 2, 4, 8, and 12 in Itching and Burning/Stinging | Itching and burning/stinging (piercing pain) were evaluated independently by the investigator as: 0 (none)=normal, no discomfort; 1 (slight)=noticeable discomfort that caused intermittent awareness; 2 (moderate)=noticeable discomfort that caused intermittent awareness and interfered occasionally with normal daily activities; 3 (strong)=definite continuous discomfort that interfered with normal daily activities. Change from Baseline was calculated as the value at Weeks 2, 4, 8, and 12 minus the value at Baseline. | Baseline; Weeks 2, 4, 8, and 12 | 
| Mean Duration of Study Product Use | Mean duration of study product use was calculated as the average total duration inclusive of missed applications of the study product. | Baseline (Day 1) through Week 12 | 
| Number of Participants Reporting the Indicated Treatment-emergent Adverse Events (AEs) Resulting in Study Product Discontinuation | An AE included, but was not limited to, any clinically significant worsening of a pre-existing condition; an event occurring from overdose (i.e., a dose higher than that indicated in the protocol) of the study product, whether accidental or intentional; an event occurring from abuse (e.g., use for nonstudy reasons) of the study product; or an event that was associated with the discontinuation of the use of the study product. | Baseline (Day 1) through Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Acne