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This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.
The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NDL-PDT/c-PDT | Experimental | Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy |
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| NDL-PDT/placebo c-PDT | Experimental | Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NDL-PDT | Drug | Metvix natural daylight photodynamic therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1 | The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I). | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Basset Seguin, PhD, MD | Hopital Saint Louis France | Principal Investigator |
| Bibiana Perez Garcia, MD | Hospital Ramón y Cajal Spain | Principal Investigator |
| Rianne Gerritsen, PhD, MD | Radboud University, Nijmegen Medical Center The Netherlands | Principal Investigator |
| Rolf-Markus Sziemies, PhD, MD | Klinik fur Dermatologie und Allergologie Germany | Principal Investigator |
| Ingrid Synnerstad, PhD, MD | Hudmottagningen Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative site | Montpellier | France | ||||
| Investigational site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Participants applied single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix cream topically followed by c- PDT (active comparator) on Day 0 (Baseline). |
| FG001 | Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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2 intra-individual groups:
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| c-PDT | Drug | Metvix conventional photodynamic therapy |
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| placebo c-PDT | Drug | Metvix placebo conventional photodynamic therapy |
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| Nantes |
| France |
| Investigational site | Nice | France |
| Investigational site | Paris | France |
| Investigative site | Rennes | France |
| Investigational site | Aachen | Germany |
| Investigational site | Berlin | Germany |
| Investigational site | Münster | Germany |
| Investigational site | Recklinghausen | Germany |
| Investigational site | Assen | Netherlands |
| Investigational site | Maastricht | Netherlands |
| Investigational site | Nijmegen | Netherlands |
| Investigational site | Huesca | Spain |
| Investigational site | Madrid | Spain |
| Investigative site | Pamplona | Spain |
| Investigational site | Valencia | Spain |
| Investigational site | Karlskoga | Sweden |
| Investigational site | Norrköping | Sweden |
Participants applied a single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix vehicle cream (placebo) followed by c-PDT on Day 0 (Baseline). |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Participants applied single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix cream topically followed by c- PDT (active comparator) on Day 0 (Baseline). |
| BG001 | Group 2 | Participants applied a single dose of Metvix cream topically followed by NDL-PDT (test treatment) on one half-face/scalp and on the contra-lateral side of face/scalp applied Metvix vehicle cream (placebo) followed by c-PDT on Day 0 (Baseline). |
| BG002 | 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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| Sex: Female, Male | Count of Participants | Participants |
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| Race | Count of Participants | Participants |
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| Phototype | Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to III. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly. | Count of Participants | Participants |
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| Duration of AK (years) | Mean | Standard Deviation | years |
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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 | Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1 | The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I). | Intent-to-treat (ITT) population included entire population enrolled and randomized. ITT analysis imputed missing data using a worst case approach and considered the lesions with missed lesion response assessment as not responded (ITT/Worst-case) lesions. | Posted | Mean | Standard Deviation | percentage change from baseline | Baseline, Week 12 |
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3 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 | NDL-PDT | Metvix natural daylight photodynamic therapy treated side | 0 | 131 | 0 | 131 | 65 | 131 |
| EG001 | c-PDT | Metvix conventional photodynamic therapy treated side | 0 | 108 | 0 | 108 | 66 | 108 |
| EG002 | Placebo c-PDT | Placebo conventional photodynamic therapy treated side | 0 | 23 | 0 | 23 | 7 | 23 |
| EG003 | Unspecific Treated Side | AE occuring outside the treated area + systemic AE | 1 | 131 | 6 | 131 | 3 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PULMONARY OEDEMA/ SUPPOSED WATER IN LUNG | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | Systematic Assessment |
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| Colon neoplasia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
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| Mallory weiss lesion in oesophagus | Gastrointestinal disorders | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash pustular | Infections and infestations | Systematic Assessment |
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| Post procedural haemorrage | Injury, poisoning and procedural complications | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain of skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Scab | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin erosion | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CTA Coordinator | Galderma R&D SNC | +33 493 95 70 85 | cta.coordinator@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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| >=65 years |
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| Male |
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| Other |
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| Phototype II |
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| Phototype III |
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| Phototype IV |
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