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

Overview

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.

Full Title of Study: “Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: September 2015

Detailed Description

Study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. Treatment sites are randomized to receive either hexylaminolaevulinate 0.2% or methylaminolaevulinate ( 16% MAL) as photosensitizers (0.25mm-thick layer). A web-based validated program (Research Randomizer) generated a randomized list to define the treatment sides. The randomization results were kept blinded from the investigators who conducted the follow-up visits, from the pathologist, and the patients. Pre-treatment procedures include application of sunscreen for 15 minutes and curettage of the treatment area. Illumination is performed using 2 hours daylight-exposure. Efficacy is assessed clinically, and histologically at 3 and 12 months by blinded observers. Pain during and after treatments and adverse reactions at one week are recorded.

Interventions

  • Drug: Hexylaminolaevulinate cream
    • 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)
  • Drug: Methylaminolaevulinate cream
    • MAL 16% is used as photosensitizer for daylight-PDT

Arms, Groups and Cohorts

  • Experimental: HAL cream and MAL cream
    • 0.2% HAL (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and MAL (Metvix, Galderma) used in a randomized split-face design

Clinical Trial Outcome Measures

Primary Measures

  • Histological Lesion Clearance
    • Time Frame: Baseline, 3 months
    • Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal)

Secondary Measures

  • Clinical Lesion Clearance
    • Time Frame: Baseline, 3 months
    • Clinical lesion clearance is observed by a blinded observer
  • Adverse Reactions
    • Time Frame: One week
    • Adverse reactions are evaluated by blinded observer at one week after treatment. Severity of the reaction ( Redness, crusting and scaling) is assessed using grading: minimal, mild, intermediate, severe.
  • Pain Assesment (Visual Analog Scale)
    • Time Frame: 12 hours
    • Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day). Of these values, the mean maximal pain is assessed.

Participating in This Clinical Trial

Inclusion Criteria

-Symmetrical actinic damage on face or scalp

Exclusion Criteria

  • Pregnancy
  • Lactation
  • Allergy to photosensitizer
  • Photodermatose

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Joint Authority for Päijät-Häme Social and Health Care
  • Collaborator
    • Helsinki University Central Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Noora E Neittaanmäki-Perttu, MD, Principal Investigator, Päijät-Häme Cnetral Hospital, Helsinki University Central Hospital
    • Mari Grönroos, MD, PhD, Study Director, Päijänne Tavastia Central Hospital

Citations Reporting on Results

Neittaanmäki-Perttu N, Grönroos M, Karppinen TT, Tani TT, Snellman E. Hexyl-5-aminolaevulinate 0·2% vs. methyl-5-aminolaevulinate 16% daylight photodynamic therapy for treatment of actinic keratoses: results of a randomized double-blinded pilot trial. Br J Dermatol. 2016 Feb;174(2):427-9. doi: 10.1111/bjd.13924. Epub 2015 Nov 20.

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