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Randomized, controlled, multi-center, double-blind, parallel-group comparison study in Subjects with moderate to severe acne vulgaris on the face.
The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% / Benzoyl Peroxide (BPO) 2.5% Gel associated with Lymecycline 300mg Capsules compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Lymecycline 300mg Capsules, in the treatment of moderate to severe acne vulgaris.
The safety of the two treatment regimens will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene 0.1% / BPO 2.5% gel | Active Comparator |
| |
| Adapalene 0.1% / BPO 2.5% Vehicle Gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene/ BPO gel with Lymecycline capsules | Drug | Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Total Lesion Count | Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate on the Investigator's Global Assessment (IGA) at Week 12 | Percentage of Subjects "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12. | Baseline and Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Paliargues | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigator site | Canberra | Australia | ||||
| Galderma Investigator site |
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Recruitment period 14/08/2009 to 21/01/2010 Type of location: hospital, private hospital and private practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adapalene 0.1% / BPO 2.5% Gel + Lymecycline | Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks |
| FG001 | Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Adapalene/ BPO vehicle gel with Lymecycline capsules | Drug | Gel: Topical to the face, once daily in the evening Capsule: 1 capsule once daily in the morning |
|
|
| Kogarah |
| Australia |
| Galderma Investigator site | Melbourne | Australia |
| Galderma Investigator site | Sydney | Australia |
| Galderma Investigator site | Brussels | Belgium |
| Galderma Investigator site | Ghent | Belgium |
| Galderma Investigator site | Leuven | Belgium |
| Galderma Investigator site | Belo Horizonte | Brazil |
| Galderma Investigator site | São Paulo | Brazil |
| Galderma Investigator site | Bordeaux | France |
| Galderma Investigator site | Cannes | France |
| Galderma Investigator site | Martigues | France |
| Galderma Investigator site | Nantes | France |
| Galderma Investigator site | Pantin | France |
| Galderma Investigator site | Pierre-Bénite | France |
| Galderma Investigator site | Cuxhaven | Germany |
| Galderma Investigator site | Darmstadt | Germany |
| Galderma Investigator site | Frankfurt | Germany |
| Galderma Investigator site | Catania | Italy |
| Galderma Investigator site | Ferrara | Italy |
| Galderma Investigator site | Mexico City | Mexico |
| Galderma Investigator site | Monterrey | Mexico |
| Galderma Investigator site | Tlalnepantla | Mexico |
| Galderma Investigator site | Zapopan | Mexico |
| Galderma Investigator site | Lodz | Poland |
| Galderma Investigator site | Eskilstuna | Sweden |
| Galderma Investigator site | Farsta | Sweden |
| Galderma Investigator site | Hägersten | Sweden |
Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adapalene 0.1% / BPO 2.5% Gel + Lymecycline | Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks |
| BG001 | Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline | Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percent Change From Baseline in Total Lesion Count | Percent change from Baseline in Total Lesion count (sum of Non-Inflammatory and Inflammatory lesions) at Week 12. | Intention to treat - Last observation carried forward | Posted | Jun 2011 | Median | Full Range | percent of change | Baseline and Week 12 |
|
|
| |||||||||||||||||||||||||||
| Secondary | Success Rate on the Investigator's Global Assessment (IGA) at Week 12 | Percentage of Subjects "Clear" or "Almost Clear" on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe) at Week 12. | Intention To treat - Last Observation Carried Forward | Posted | Jun 2011 | Number | percent of subjects | Baseline and Week 12 |
|
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12 weeks.
All clinical medical events, occured after Subject's consent signed and during the study, whether observed by the Investigator or reported by the Subject and whether or not thought to be product- or study procedure-related were considered adverse events and collected.
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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 0.1% / BPO 2.5% Gel + Lymecycline | Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks | 0 | 191 | 25 | 191 | ||
| EG001 | Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline | Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks | 0 | 187 | 26 | 187 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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Disclosure agreement in full force and effect for a period of 10 years.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Florence Paliargues / CPM | Galderma | +33492952957 | florence.paliargues@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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| ID | Term |
|---|---|
| D000068816 | Adapalene |
| D008194 | Lymecycline |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
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| >=65 years |
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| Male |
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| Mexico |
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| Brazil |
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| Poland |
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| Belgium |
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| Australia |
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| Germany |
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| Italy |
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| Sweden |
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