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 Details — Status: Recruiting

Administrative data

• NCT number: NCT02149342
• Other study ID #: 2013-001389-40
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 19, 2014
• Last updated: December 3, 2014
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: December 2014
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: Noora E Neittaanmäki-Perttu, MD
• Phone: +358407190362
• Email: noora.neittaanmaki[@]fimnet.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Symmetrical actinic damage on face or scalp

Exclusion Criteria:

• Pregnancy

• Lactation

• Allergy to photosensitizer

• Photodermatose

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

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Hexylaminolaevulinate cream
0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014) 2% Hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) cream (2015)
• Methylaminolaevulinate cream
MAL 16% is used as photosensitizer for daylight-PDT

Locations

Country	Name	City	State
Finland	Päijät-Häme Central Hospital	Lahti

Sponsors (2)

Lead Sponsor	Collaborator
Joint Authority for Päijät-Häme Social and Health Care	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological lesion clearance	Punch biopsies symmetrically on treatment fields prior to treatment and at 3 months, blinded observer (pathologist). HE- and p53-stainings.	3 months	No
Secondary	Clinical lesion clearance	Blinded observer	3 months and 12 months	No
Secondary	Pain assesment (visual analog scale)	Pain is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day)	12 hours	Yes
Secondary	Adverse reactions	Blinded observer	One week	Yes
Secondary	Clerance of field cancerization in hyperspectral images	Hyperspectral images prior to treatment and at 3 and 12 months	3 and 12 months	No