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The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metvix and daylight | Experimental |
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| Metvix and lamp | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metvix and natural daylight PDT | Drug | Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area. |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Response | Percent of lesions treated at Baseline, in complete response at Week 12 | Week12 |
| Pain Score | Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain) | Baseline (during procedure), assessed after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Shumack | St George Dermatology and skin Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational site | Phillip | Australian Capital Territory | Australia | |||
| Galderma Investigational Site |
No significant events
100 subjects recruited from March 2012 to May 2012 in private practice and clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects Enrolled | Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Metvix and conventional PDT | Drug | Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area. |
|
| Kogarah |
| New South Wales |
| Australia |
| Galderma Investigational site | Sydney | New South Wales | Australia |
| Galderma Investigational site | Westmead | New South Wales | Australia |
| Galderma Investigational site | Woolloongabba | Queensland | Australia |
| Galderma Investigational site | Carlton | Victoria | Australia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects Enrolled | Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side |
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Lesion Response | Percent of lesions treated at Baseline, in complete response at Week 12 | Only Per Protocol subjects are included in this analysis | Posted | Mean | Standard Deviation | percentage of lesions complete response | Week12 |
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| Primary | Pain Score | Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain) | ITT population | Posted | Mean | Standard Deviation | units on a scale | Baseline (during procedure), assessed after procedure |
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From baseline to study end.
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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 | Metvix and Daylight | Metvix and daylight Photodynamic Therapy | 9 | 100 | 39 | 100 | ||
| EG001 | Metvix and Lamp | Metvix and conventional Phototodynamic Therapy | 9 | 100 | 59 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute coronary syndrome | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | not related |
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| deep vein thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment | not related |
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| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | not related |
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| gastroinstestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment | not related |
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| rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | not related |
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| coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment | not related |
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| prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment | not related |
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| inguinal hernia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | not related |
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| diverticulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | not related |
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| haemorrhoids | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | not related |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment | not related |
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| erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| pain of skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| scab | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| skin reaction | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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Disclosure agreement covered by contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cyril Moulin | Galderma | +33 4 92 38 30 14 | cyril.moulin@galderma.com |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
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