Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Summary
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).
Timeline
- Start
- 2012-03
- Primary completion
- 2012-11
- Completion
- 2013-03
Outcome
Mixed primary results
registry analysis (unspecified test); Metvix and Daylight vs Metvix and Lamp; p = 0.0345; Mean Difference (Final Values) -3.5; paired Student's t statistic NCT01475071 ↗
registry MEAN Metvix and Daylight: 89.2 (Standard Deviation 15.0) percentage of lesions complete response NCT01475071 ↗
registry analysis (unspecified test); Metvix and Daylight vs Metvix and Lamp; p <0.001; Mean Difference (Final Values) -4.9; Wilcoxon (Mann-Whitney) NCT01475071 ↗
registry MEAN Metvix and Daylight: 0.8 (Standard Deviation 1.2) units on a scale NCT01475071 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | methyl aminolevulinate | Small molecule | 160 unknown | — |