Phase 2
Completed N=14
Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL
Actinic Keratoses
Source: ClinicalTrials.gov NCT02149342 ↗
Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Histological Lesion Clearance — 38.5; 69.2 percentage of complete histological clea
Summary
This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Histological Lesion Clearance |
38.5; 69.2 | — |
| SECONDARY Clinical Lesion Clearance |
73.4; 77.8 | — |
| SECONDARY Adverse Reactions |
14; 14 | — |
| SECONDARY Pain Assesment (Visual Analog Scale) |
0.86; 1 | — |
Eligibility Criteria
Inclusion Criteria
-Symmetrical actinic damage on face or scalp
Exclusion Criteria
- Pregnancy
- Lactation
- Allergy to photosensitizer
- Photodermatose
Data sourced from ClinicalTrials.gov (NCT02149342). 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.