Phase 3
N=26
Actinic Keratoses Treatment With Metvix® in Combination With Light
Actinic Keratoses
Bottom Line
View on ClinicalTrials.gov: NCT02373371 ↗Enrolled (actual)
26
Serious AEs
7.7%
Results posted
Apr 2019
Primary outcome: Primary: Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 — 19.6; 20.0 number of lesions — p=0.8460
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Metvix® (Drug); Photodynamic Therapy Blue light (Procedure); Photodynamic Therapy Daylight (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Limoges
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12 |
19.6; 20.0 | 0.8460 |
| SECONDARY Pain Assesment |
1.2; 5.1 | — |
| SECONDARY Lesions Disappearance Rate at 1 Months From Baseline. |
89.6; 94.6 | 0.0005 sig |
| SECONDARY Lesions Disappearance Rate at 6 Months From Baseline. |
90.9; 94.7 | 0.0001 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 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 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
Data sourced from ClinicalTrials.gov (NCT02373371). 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.