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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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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 in subjects with mild actinic keratoses (intra-individual comparison)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daylight | Experimental | Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline |
|
| Conventional treatment | Active Comparator | Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metvix® | Drug |
| ||
| Photodynamic Therapy Blue light |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 | The number of lesions is assessed at baseline (before treatment) and 12 weeks later. The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assesment | Pain assesment with a VAS Pain scale Visual analog scale [VAS] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). | at inclusion (after treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limoges University Hospital | Limoges | 87042 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31955461 | Result | Assikar S, Labrunie A, Kerob D, Couraud A, Bedane C. Daylight photodynamic therapy with methyl aminolevulinate cream is as effective as conventional photodynamic therapy with blue light in the treatment of actinic keratosis: a controlled randomized intra-individual study. J Eur Acad Dermatol Venereol. 2020 Aug;34(8):1730-1735. doi: 10.1111/jdv.16208. Epub 2020 Feb 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Daylight | Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug |
| FG001 | Conventional Treatment | Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Daylight | Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug |
| BG001 | Conventional Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 | The number of lesions is assessed at baseline (before treatment) and 12 weeks later. The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients. | Posted | Mean | Standard Deviation | number of lesions | Baseline and Week 12 |
|
which adverse event data were collected over 6 months
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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 | Daylight | Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline Metvix® Photodynamic Therapy Daylight: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ischaemic stroke | Nervous system disorders | MedDRA 18.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | CHU de Limoges | 0555058616 | +33 | abdeslam.bentaleb@chu-limoges.fr |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C475457 | methyl 5-aminolevulinate |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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| Procedure |
Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug |
|
| Photodynamic Therapy Daylight | Procedure | Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug |
|
| Lesions Disappearance Rate at 1 Months From Baseline. |
The number of lesions is assessed at baseline (before treatment) and 1 month later. The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 1 month "/nubmer of lesions at baseline |
| 0(baseline),1 month |
| Lesions Disappearance Rate at 6 Months From Baseline. | The number of lesions is assessed at baseline (before treatment) and 6 month later. The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 6 month "/nubmer of lesions at baseline | 0(baseline), 6 month |
Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
Metvix®
Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
|
|
|
| Secondary | Pain Assesment | Pain assesment with a VAS Pain scale Visual analog scale [VAS] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). | Posted | Mean | Standard Deviation | units on a scale | at inclusion (after treatment) |
|
|
|
| Secondary | Lesions Disappearance Rate at 1 Months From Baseline. | The number of lesions is assessed at baseline (before treatment) and 1 month later. The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 1 month "/nubmer of lesions at baseline | Posted | Mean | Standard Deviation | percentage of disappeared lesions | 0(baseline),1 month |
|
|
|
|
| Secondary | Lesions Disappearance Rate at 6 Months From Baseline. | The number of lesions is assessed at baseline (before treatment) and 6 month later. The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 6 month "/nubmer of lesions at baseline | Posted | Mean | Standard Deviation | percentage of disappeared lesions | 0(baseline), 6 month |
|
|
|
|
| 0 |
| 13 |
| 1 |
| 13 |
| 0 |
| 13 |
| EG001 | Conventional Treatment | Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline Metvix® Photodynamic Therapy Blue light: Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug | 0 | 13 | 1 | 13 | 0 | 13 |
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| D017437 |
| Skin and Connective Tissue Diseases |