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

Joint Authority for Päijät-Häme Social and Health Care

Status and phase: Completed; Phase 2; Phase 1

Conditions: Actinic Keratoses

Treatments: Drug: Hexylaminolaevulinate cream; Drug: Methylaminolaevulinate cream

Study type: Interventional

Funder types: Other

Identifiers

NCT02149342

2013-001389-40

Details and patient eligibility

About

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 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Symmetrical actinic damage on face or scalp

Exclusion criteria

• Pregnancy
• Lactation
• Allergy to photosensitizer
• Photodermatose

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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14 participants in 1 patient group

HAL cream and MAL cream

Experimental group

Description:

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

Treatment:

Drug: Methylaminolaevulinate cream

Drug: Hexylaminolaevulinate cream