Phase 2 N=14 Randomized Double-blind Treatment

Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL

Actinic Keratoses

Bottom Line

View on ClinicalTrials.gov: NCT02149342 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: Histological Lesion Clearance — 38.5; 69.2 percentage of complete histological clea

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Hexylaminolaevulinate cream (Drug); Methylaminolaevulinate cream (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Joint Authority for Päijät-Häme Social and Health Care
Primary completion: Sep 2015

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	—

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.

Eligibility Criteria

Inclusion Criteria

-Symmetrical actinic damage on face or scalp

Exclusion Criteria

Pregnancy
Lactation
Allergy to photosensitizer
Photodermatose

View full record on ClinicalTrials.gov →

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.