Clinical trial · Interventional
Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| c-PDT | Drug | — | UNRESOLVED |
| NDL-PDT | Drug | — | UNRESOLVED |
| placebo c-PDT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NDL-PDT/c-PDT
- description
- Metvix natural daylight photodynamic therapy and Metvix conventional photodynamic therapy
- interventionNames
- Drug: NDL-PDT
- Drug: c-PDT
- type
- EXPERIMENTAL
- label
- NDL-PDT/placebo c-PDT
- description
- Metvix natural daylight photodynamic therapy and Metvix-placebo conventional photodynamic therapy
- interventionNames
- Drug: NDL-PDT
- Drug: placebo c-PDT
Primary outcomes (1)
- measure
- Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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,
References
Publications (0)
Data not yet available