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

J

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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