Clinical trial · Interventional
Actinic Keratoses Treatment With Metvix® in Combination With Light
Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
NCT02373371CI-TRIAL-00092722completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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)
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 |
|---|---|---|---|
| Metvix® | Drug | Methyl Aminolevulinate | ALIAS |
| Photodynamic Therapy Blue light | Procedure | — | UNRESOLVED |
| Photodynamic Therapy Daylight | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Daylight
- description
- Metvix® (160mg/g) and Photodynamic Therapy Daylight One session at baseline
- interventionNames
- Drug: Metvix®
- Procedure: Photodynamic Therapy Daylight
- type
- ACTIVE_COMPARATOR
- label
- Conventional treatment
- description
- Metvix® (160mg/g) and Photodynamic Therapy Blue light One session at baseline
- interventionNames
- Drug: Metvix®
- Procedure: Photodynamic Therapy Blue light
Primary outcomes (1)
- measure
- Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female above 18 years; * Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs); Exclusion Criteria: * Subject with clinical diagnosis of at least one severe AK on TAs * Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs; * Subject with pigmented AK on the TAs
References
Publications (1)
- RESULTAssikar 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. PMID 31955461