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

NCT02149342 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-07-11

Study results available
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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.

Conditions

  • Actinic Keratoses

Interventions

DRUG

Hexylaminolaevulinate cream

0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)

DRUG

Methylaminolaevulinate cream

MAL 16% is used as photosensitizer for daylight-PDT

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Joint Authority for Päijät-Häme Social and Health Care

    lead OTHER

Principal Investigators

  • Noora E Neittaanmäki-Perttu, MD · Päijät-Häme Cnetral Hospital, Helsinki University Central Hospital

  • Mari Grönroos, MD, PhD · Päijät Häme Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02149342 on ClinicalTrials.gov