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The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks |
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| 2 | Experimental | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks |
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| 3 | Experimental | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks |
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| 4 | Active Comparator | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene BPO Gel standard daily overnight application | Drug | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. | Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry Tan, MD | Windsor, ON, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site | Windsor | Ontario | Canada | |||
| Galderma Investigational Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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Recruitment period: 23 APR 2009 to 09 SEP 2009 in three private practice Canadian centres. Two centers used a central IRB, and the other used a local IRB.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene-BPO Gel 3h | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks |
| FG001 | Adapalene-BPO Gel EoD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Adapalene-BPO 3-hour daily application before bedtime | Drug | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks |
|
|
| Adapalene-BPO Gel every other day application | Drug | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks |
|
|
| Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion | Drug | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks |
|
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| Montreal |
| Quebec |
| Canada |
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
| FG002 | Adapalene-BPO Gel Cetaphil | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks |
| FG003 | Adapalene-BPO Gel StD | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene-BPO Gel 3h | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks |
| BG001 | Adapalene-BPO Gel EoD | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks |
| BG002 | Adapalene-BPO Gel Cetaphil | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks |
| BG003 | Adapalene-BPO Gel StD | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. | Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit. | Posted | Oct 2010 | Mean | Standard Deviation | Scores on a scale | Week 4 |
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12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adapalene-BPO Gel 3h | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks | 0 | 32 | 8 | 32 | ||
| EG001 | Adapalene-BPO Gel EoD | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks | 0 | 32 | 5 | 32 | ||
| EG002 | Adapalene-BPO Gel Cetaphil | Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks | 0 | 29 | 8 | 29 | ||
| EG003 | Adapalene-BPO Gel StD | Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week | 0 | 30 | 6 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
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| nasopharyngitis | Infections and infestations | Systematic Assessment |
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| sunburn | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| dermatitis contact | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| impetigo | Infections and infestations | Systematic Assessment |
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| upper track respiratory infection | Infections and infestations | Systematic Assessment |
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| skin burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| herpes simplex | Infections and infestations | Systematic Assessment |
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| tooth abscess | Infections and infestations | Systematic Assessment |
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| skin oedema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| mouth injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| face oedema | General disorders | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| arthropod bite | Injury, poisoning and procedural complications | Systematic Assessment |
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| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| pharyngitis | Infections and infestations | Systematic Assessment |
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| skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| epicondylitis | Injury, poisoning and procedural complications | Systematic Assessment |
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Any intent of the investigator to publish or disclose in any way the information requires the sponsor's prior written approval. The investigator shall provide their draft of such publication to sponsor for review and approval at least 2 months prior to the date of the intended publication. Sponsor shall have the absolute right to determine whether information may be published by the investigator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Charles Dhuin | Galderma | +33492952921 | jean-charles.dhuin@galderma.com |
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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