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

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ClinicalTrials.gov Identifier: NCT02149342
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Helsinki University Central Hospital
Information provided by (Responsible Party):
Joint Authority for Päijät-Häme Social and Health Care

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: Hexylaminolaevulinate cream Drug: Methylaminolaevulinate cream Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate
Study Start Date : May 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Hexylaminolaevulinate cream
0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)
Other Names:
  • HAL
  • Hexvix, Photocure

Drug: Methylaminolaevulinate cream
MAL 16% is used as photosensitizer for daylight-PDT
Other Names:
  • 16% Methylaminolaevulinate (Metvix, Galderma) cream
  • MAL


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Clearance of Field Cancerization in Hyperspectral Images [ Time Frame: 3 months ]
    Data not collected


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Symmetrical actinic damage on face or scalp

Exclusion Criteria:

  • Pregnancy
  • Lactation
  • Allergy to photosensitizer
  • Photodermatose
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149342


Locations
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Finland
Päijät-Häme Central Hospital
Lahti, Finland, 15850
Sponsors and Collaborators
Joint Authority for Päijät-Häme Social and Health Care
Helsinki University Central Hospital
Investigators
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Principal Investigator: Noora E Neittaanmäki-Perttu, MD Päijät-Häme Cnetral Hospital, Helsinki University Central Hospital
Study Director: Mari Grönroos, MD, PhD Päijänne Tavastia Central Hospital
More Information
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Publications of Results:

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Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT02149342    
Other Study ID Numbers: 2013-001389-40
First Posted: May 29, 2014    Key Record Dates
Results First Posted: July 11, 2016
Last Update Posted: July 11, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: International peer-reviewed publication
Keywords provided by Joint Authority for Päijät-Häme Social and Health Care:
Actinic keratoses
Daylight-PDT
Hexylaminolaevulinate
HAL
 Methylaminolaevulinate
MAL
Hyperspectral imaging
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
 Methyl 5-aminolevulinate
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents