Clinical trial NCT01893203: Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)
Official title: Treatment of AKs With Daylight-PDT: Comparing Two Photosensitizers (BF-200 ALA and MAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Actinic Keratoses
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
First posted: 2013-07-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Actinic keratoses (AKs) are superficial premalignant skin lesions that can progress into an invasive or metastatic squamous cell carcinoma. AKs can be treated with photodynamic therapy (PDT), of which cure rate compares to cryo surgery with an excellent cosmesis. In PDT the AK lesions are first curettaged, then a photosensitizer is applied on the skin and let to absorb for 3 hours. The skin is illuminated using a blue or red light source light source depending on the photosensitizer, which induces activation of protoporphyrin IX (PpIX) and phototoxic reaction destroying the cancer cells.

The approved photosensitizers in Europe are methyl-aminolevulinic acid cream, (MAL, Metvix™, Galderma), a patch containing 5-aminolevulinic acid (5-ALA, Alacare®, Spirig AG) and 5-aminolevulinic acid gel (BF-200 ALA, Ameluz®, Biofrontera AG) to be used with a red LED light (630-635 nm). In North America a 5-aminolevulinic acid stick (5-ALA, Levulan® Kerastick) can also be used with a blue light source (417 nm).

PpIX absorption peaks are within the visual spectrum of light, which allows PpIX daylight activation. During natural daylight PDT (NDL-PDT) protocol, PpIX is continuously activated during its development, whereas in conventional PDT (LED-PDT) using red LED lamps, large amounts of accumulated PpIX are momentarily activated.

Since skin field cancerization refers to presence of different degrees of visible and invisible dysplastic changes, the whole area should be treated to prevent the development of non-melanoma skin cancers (NMSCs). NDL-PDT enables treatment of field cancerization in one sitting whereas LED-PDT may need repeated illuminations to cover the whole area. NDL-PDT results in enhanced cost-efficacy due to reduced staff expenses, since there's no need for sensitizer absorption and illumination.

At the moment two photosensitizers have marketing authorization in Finland, ALA (Ameluz®) and MAL (Metvix™). We are piloting a study comparing the efficacy of these two light sensitizers in NDL-PDT. The efficacy of the treatments will be assessed clinically, histopathologically and immunohistochemically.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* pregnancy
* lactation
* lack of compliance

Primary outcomes:
measure: Histological Lesion Clearance
timeFrame: 0 (baseline) and 3 months
Secondary outcomes:
measure: Pain
timeFrame: 12 hours
measure: Clinical Lesion Clearance
timeFrame: 3 months
Other outcomes:
measure: Adverse Reactions
timeFrame: 1 week
Locations:
city: Lahti
country: Finland
facility: Päijät-Häme Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Noora E Neittaanmäki-Perttu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Päijät Häme Central Hospital
name: Toni T Karppinen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Päijät Häme Central Hospital
name: Taneli Tani, PhD
role: STUDY_CHAIR
References: