Phase 3
N=100
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Actinic Keratoses
Bottom Line
View on ClinicalTrials.gov: NCT01475071 ↗Enrolled (actual)
100
Serious AEs
9.0%
Results posted
Apr 2016
Primary outcome: Primary: Lesion Response — 89.2; 92.8 percentage of lesions complete response — p=0.0345
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metvix and natural daylight PDT (Drug); Metvix and conventional PDT (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lesion Response |
89.2; 92.8 | 0.0345 sig |
| PRIMARY Pain Score |
0.8; 5.7 | <0.001 sig |
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).
Eligibility Criteria
Inclusion Criteria
- Male or female above 18 years;
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01475071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.