Clinical trial · Interventional
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.
NCT01475071CI-TRIAL-00050167CoMetcompletedPhase 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 with Aktilite™ lamp 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metvix and conventional PDT | Drug | — | UNRESOLVED |
| Metvix and natural daylight PDT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metvix and daylight
- interventionNames
- Drug: Metvix and natural daylight PDT
- type
- ACTIVE_COMPARATOR
- label
- Metvix and lamp
- interventionNames
- Drug: Metvix and conventional PDT
Primary outcomes (2)
- measure
- Lesion Response
- timeFrame
- Week12
- description
- Percent of lesions treated at Baseline, in complete response at Week 12
- measure
- Pain Score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female above 18 years; 2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs); Exclusion Criteria: 1. Subject with clinical diagnosis of at least one severe AK on TAs 2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs; 3. Subject with pigmented AK on the TAs
References
Publications (0)
Data not yet available
No reference posted for this study.