Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses

Study Overview
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Brief Summary
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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.

Official Title
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Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: NDL-PDT
* Drug: c-PDT
* Drug: placebo c-PDT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs Exclusion Criteria: Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas Subject with pigmented AK on the treated areas Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons Subject with porphyria,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 2 intra-individual groups: Metvix NDL-PDT / Metvix c-PDT Metvix NDL-PDT / Placebo c-PDT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NDL-PDT/c-PDT<br>Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy | Drug: NDL-PDT<br>* Metvix natural daylight photodynamic therapy<br>* Other names: Metvix NDL-PDT;Drug: c-PDT<br>* Metvix conventional photodynamic therapy<br>* Other names: Metvix c-PDT;|
| Experimental: NDL-PDT/placebo c-PDT<br>Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy | Drug: NDL-PDT<br>* Metvix natural daylight photodynamic therapy<br>* Other names: Metvix NDL-PDT;Drug: placebo c-PDT<br>* Metvix placebo conventional photodynamic therapy<br>* Other names: Metvix placebo c-PDT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actinic keratoses, photodynamic therapy, natural daylight