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Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses. (CoMet)
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).
Details
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 100 |
| Start date | 2012-03 |
| Completion | 2013-03 |
Conditions
- Actinic Keratoses
Interventions
- Metvix and natural daylight PDT
- Metvix and conventional PDT
Primary outcomes
- Lesion Response — Week12
Percent of lesions treated at Baseline, in complete response at Week 12 - Pain Score — Baseline (during procedure), assessed after procedure
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
Countries
Australia