Clinical trial NCT02149342: Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL
Official title: Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Actinic Keratoses
Keywords: Actinic keratoses
Daylight-PDT
Hexylaminolaevulinate
HAL
Methylaminolaevulinate
MAL
Hyperspectral imaging
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2014-05-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

-Symmetrical actinic damage on face or scalp

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy to photosensitizer
* Photodermatose

Primary outcomes:
measure: Histological Lesion Clearance
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Clinical Lesion Clearance
timeFrame: Baseline, 3 months
measure: Adverse Reactions
timeFrame: One week
measure: Pain Assesment (Visual Analog Scale)
timeFrame: 12 hours
Other outcomes:
measure: Clearance of Field Cancerization in Hyperspectral Images
timeFrame: 3 months
Locations:
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
Study officials:
affiliation: Päijät-Häme Cnetral Hospital, Helsinki University Central Hospital
name: Noora E Neittaanmäki-Perttu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Päijät Häme Central Hospital
name: Mari Grönroos, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Neittaanmaki-Perttu N, Gronroos 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. No abstract available.