Phase 4
N=14
Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)
Multiple Actinic Keratoses
Bottom Line
View on ClinicalTrials.gov: NCT01893203 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Histological Lesion Clearance — 61.5; 38.5 percentage of complete clearance — p=0.375
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- BF-200 ALA cream (Drug); MAL cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histological Lesion Clearance |
61.5; 38.5 | 0.375 |
| SECONDARY Pain |
1.7; 1.9 | — |
| SECONDARY Clinical Lesion Clearance |
84.5; 74.2 | — |
Summary
The aim of the study is to compare the efficacy of two photosensitizers, methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the treatment of facial actinic keratosis. We use randomized, double-blinded prospective study design. The efficacy will be assessed clinically, histopathologically and immunohistochemically.
Eligibility Criteria
Inclusion Criteria
- actinic keratoses symmetrically on face or scalp
- age over 18 years
- there must be at minumum one ak sized 6mm2 symmetrically on both sides
- patients must be able to make the decision to attend independently
Exclusion Criteria
- pregnancy
- lactation
- lack of compliance
Data sourced from ClinicalTrials.gov (NCT01893203). 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.