Phase 3
Completed N=131
Phase 3b Study of Metvix NDL-PDT Versus Metvix c-PDT in Subjects With Actinic Keratoses
Actinic Keratoses
Source: ClinicalTrials.gov NCT01821391 ↗
Enrolled (actual)
131
Serious AEs
1.5%
Results posted
Dec 2020
Primary outcomePrimary: Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1 — 68.4; 71.5 percentage change from baseline — p==0.2665
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study was to be conducted as a multi-centre, randomized, investigator-blinded, active and vehicle-controlled, intra-individual (split-face/scalp) non-inferiority (regarding efficacy) and superiority (regarding pain) study.
The primary purpose of this study is to demonstrate the non-inferiority of NDL-PDT compared to c-PDT in terms of lesion complete response rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1 |
68.4; 71.5 | =0.2665 |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of mild (Grade 1) and/or moderate (Grade 2) AKs on the face or the scalp on treated areas
- Subject with two symmetrical treated areas half scalps or two half faces excluding ears, chin, bridge of the nose, eyelids and lips inside the vermillion border): no more than a twofold difference in terms of total number of lesions between the two TAs
Exclusion Criteria
- Subject with clinical diagnosis of at least one severe (Grade 3) AK on treated areas
- Subject with pigmented AK on the treated areas
- Immuno-compromised Subject for idiopathic, disease specific or therapeutic reasons
- Subject with porphyria,
Data sourced from ClinicalTrials.gov (NCT01821391). 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. Informational only — not medical advice.