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

NCT02149342 | Completed Phase 1 Results DMC

• 1 other identifier: 2013-001389-40
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Keywords

Actinic keratoses; Daylight-PDT; Hexylaminolaevulinate; HAL; Methylaminolaevulinate; MAL; Hyperspectral imaging

Outcome Measures

Primary Outcomes (1)

• Histological Lesion Clearance

  Punch biopsies were taken symmetrically on both treatment fields from equally graded \>6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (\<10 % normal)

  Baseline, 3 months

Secondary Outcomes (3)

• Clinical Lesion Clearance

  Baseline, 3 months

• Adverse Reactions

  One week

• Pain Assesment (Visual Analog Scale)

  12 hours

Other Outcomes (1)

• Clearance of Field Cancerization in Hyperspectral Images

  3 months

Study Arms (1)

HAL cream and MAL cream

EXPERIMENTAL

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

Drug: Hexylaminolaevulinate cream; Drug: Methylaminolaevulinate cream

Interventions

Hexylaminolaevulinate cream DRUG

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

Also known as: HAL, Hexvix, Photocure

HAL cream and MAL cream

Methylaminolaevulinate cream DRUG

MAL 16% is used as photosensitizer for daylight-PDT

Also known as: 16% Methylaminolaevulinate (Metvix, Galderma) cream, MAL

HAL cream and MAL cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symmetrical actinic damage on face or scalp

You may not qualify if:

• Pregnancy
• Lactation
• Allergy to photosensitizer
• Photodermatose

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead
• Helsinki University Central Hospital: collaborator

Study Sites (1)

Päijät-Häme Central Hospital

Lahti, Lahti, 15850, Finland

Location

Related Publications (1)

• 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.

  PMID: 26011755 RESULT

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

5-aminolevulinic acid hexyl ester; methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

As the study was conducted as a single center pilot study, the results should be confirmed in a larger trial also valuing the patient complete response rates. A further limitation was we did not record light-doses.

Results Point of Contact

• Title: Md, PhD Noora Neittaanmäki-Perttu
• Organization: Helsinki university central hospital

noora.neittaanmaki@fimnet.fi

+358407190362

Study Officials

• Noora E Neittaanmäki-Perttu, MD

  Päijät-Häme Cnetral Hospital, Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Mari Grönroos, MD, PhD

  Päijät Häme Central Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

FI (1)