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Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2% and 2%HAL With 16%MAL

Actinic Keratoses Clinical Trial

Official title:
Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% and 2% Hexylaminolaevulinate With 16% Methylaminolaevulinate

Clinical Trial 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.

Clinical Trial Description

Study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. Treatment sites are randomized to receive either hexylaminolaevulinate or methylaminolaevulinate ( 16% MAL) as photosensitizers (0.25mm-thick layer). In the first study year (2014) we use a very-low concentration 0.2% HAL, and during second study period (2015) we will continue with a low concentration 2% HAL for dose finding. 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02149342
Study type Interventional
Source Joint Authority for Päijät-Häme Social and Health Care
Contact Noora E Neittaanmäki-Perttu, MD
Phone +358407190362
Email noora.neittaanmaki@fimnet.fi
Status Recruiting
Phase Phase 1/Phase 2
Start date May 2014
Completion date May 2016
View Details
See also
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