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Completed

NCT Number: NCT02149342

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

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Päijät-Häme Central Hospital

Lahti, 15850, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-Symmetrical actinic damage on face or scalp

Exclusion criteria

  • Pregnancy
  • Lactation
  • Allergy to photosensitizer
  • Photodermatose

Treatment and study plan

Hexylaminolaevulinate cream

Drug

0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)

Other names: HAL, Hexvix, Photocure

Methylaminolaevulinate cream

Drug

MAL 16% is used as photosensitizer for daylight-PDT

Other names: 16% Methylaminolaevulinate (Metvix, Galderma) cream, MAL

Primary outcomes

  1. 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 outcomes

  1. Clinical Lesion Clearance

    Time frame: Baseline, 3 months

    Clinical lesion clearance is observed by a blinded observer

  2. 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.

  3. 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.

Other outcomes

  1. Clearance of Field Cancerization in Hyperspectral Images

    Time frame: 3 months

    Data not collected

Sponsors and collaborators

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care

Other

Collaborators

  • Helsinki University Central Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 29, 2014
Registry last updated
Jul 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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