Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)

NCT01893203 | Completed Phase 4 Results DMC

• 2 other identifiers: R13073 / Q2572013-002108-15
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the efficacy of two photosensitizers, methyl-aminolaevulinate (MAL) and 5-aminolaevulinic nanoemulsion (BF-200 ALA) in the treatment of facial actinic keratosis. We use randomized, double-blinded prospective study design. The efficacy will be assessed clinically, histopathologically and immunohistochemically.

Conditions

Multiple Actinic Keratoses

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)

  0 (baseline) and 3 months

Secondary Outcomes (2)

• Pain

  12 hours

• Clinical Lesion Clearance

  3 months

Other Outcomes (1)

• Adverse Reactions

  1 week

Study Arms (1)

BF-200 ALA vs MAL

OTHER

BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design

Drug: BF-200 ALA cream; Drug: MAL cream

Interventions

BF-200 ALA cream DRUG

The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then sun protection factor (SPF) 20 cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Ameluz cream on the area. After appropriate absorption time of 30 minutes, the patients will be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.

Also known as: 5-aminolaevulenic acid nanoemulsion, Ameluz

BF-200 ALA vs MAL

MAL cream DRUG

The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then SPF20 sun protection cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Metvix cream on the area. After appropriate absorption time of 30 minutes, the patientswill be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.

Also known as: methylaminolevulinic acid, Metvix

BF-200 ALA vs MAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• actinic keratoses symmetrically on face or scalp
• age over 18 years
• there must be at minumum one ak sized 6mm2 symmetrically on both sides
• patients must be able to make the decision to attend independently

You may not qualify if:

• pregnancy
• lactation
• lack of compliance

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead

Study Sites (1)

Päijät-Häme Central Hospital

Lahti, 15850, Finland

Location

MeSH Terms

Interventions

Aminolevulinic Acid; methyl 5-aminolevulinate

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Noora Neittaanmäki-Perttu
• Organization: Helsinki university hospital

noora.neittaanmaki@fimnet.fi

+358407190362

Study Officials

• Noora E Neittaanmäki-Perttu, MD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

• Toni T Karppinen, MD

  Päijät Häme Central Hospital

  PRINCIPAL INVESTIGATOR

• Taneli Tani, PhD

  Päijät Häme Central Hospital

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: July 2, 2013
• First Posted: July 8, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-05

Locations

FI (1)