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

NCT ID: NCT02149342

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-09-30

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.

Conditions

Actinic Keratoses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HAL cream and MAL cream

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

Group Type: EXPERIMENTAL

Hexylaminolaevulinate cream

Intervention Type: DRUG

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

Methylaminolaevulinate cream

Intervention Type: DRUG

MAL 16% is used as photosensitizer for daylight-PDT

Interventions

Hexylaminolaevulinate cream

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

Intervention Type: DRUG

Methylaminolaevulinate cream

MAL 16% is used as photosensitizer for daylight-PDT

Intervention Type: DRUG

Other Intervention Names

HAL; Hexvix, Photocure; 16% Methylaminolaevulinate (Metvix, Galderma) cream; MAL

Eligibility Criteria

Inclusion Criteria

-Symmetrical actinic damage on face or scalp

Exclusion Criteria

• Pregnancy
• Lactation
• Allergy to photosensitizer
• Photodermatose

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Joint Authority for Päijät-Häme Social and Health Care

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noora E Neittaanmäki-Perttu, MD

Role: PRINCIPAL_INVESTIGATOR

Päijät-Häme Cnetral Hospital, Helsinki University Central Hospital

Mari Grönroos, MD, PhD

Role: STUDY_DIRECTOR

Päijät Häme Central Hospital

Locations

Päijät-Häme Central Hospital

Lahti, Lahti, Finland

Countries

Finland

References

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.

Reference Type: RESULT

PMID: 26011755 (View on PubMed)

Other Identifiers

2013-001389-40

Identifier Type: -

Identifier Source: org_study_id