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Trial record 12 of 1354 for:    ALA

Daylight PDT for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)

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ClinicalTrials.gov Identifier: NCT02464709
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : November 27, 2017
Sponsor:
Collaborators:
Päijänne Tavastia Central Hospital
Tampere University Hospital
Vaasa Central Hospital, Vaasa, Finland
University of Tampere
STUK - Radiation and Nuclear Safety Authority: Finland
Information provided by (Responsible Party):
Joint Authority for Päijät-Häme Social and Health Care

Brief Summary:
This study compares two photosensitizing creams' BF-200 ALA's (aminolevulinic acid, Ameluz®) and MAL's (methyl 5-aminolevulinate, Metvix®) efficacy on actinic keratoses in natural daylight photodynamic therapy (NDL-PDT). The participants' facial skin or scalp will be randomized in two sides and one side is treated with BF-200 ALA and the other side with MAL. Result of the treatment is assessed with clinical examination 12 months after treatment. The investigators will also compare delayed skin reactions after treatment and cost-effectiveness of both photosensitizer creams.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Natural Daylight Photodynamic Therapy Drug: Aminolevulinic Acid Drug: Methyl 5-aminolevulinate Phase 4

Detailed Description:

Photodynamic therapy (PDT) is a widely used method in dermatology clinics for treatment of superficial skin cancers and premalignant lesions. Actinic keratoses (AKs) are premalignant skin lesions which develop due to long-lasting sun exposure and in time can progress into squamocellular skin cancer if left untreated. The incidence of AKs and skin cancers is rapidly booming as the elderly population increases in western countries. It is crucial to treat AKs early and effectively considering their tendency to progress into malign cancer. The current general consensus for treating AKs is to treat large sun-damaged skin areas simultaneously instead of separate AK lesions. Term "skin field cancerization" refers to presence of different degrees of visible and invisible dysplastic changes in widely sun-damaged skin. Natural daylight mediated photodynamic therapy (NDL-PDT) is a well-suited method for treating large field-cancerized skin areas.

In PDT a photosensitizing cream is applied on the skin and let to absorb. After absorption to the skin cells the photosensitizer changes into protoporphyrin IX (PpIX). PpIX reacts with visible light causing a phototoxic reaction which destroys cancer cells targetedly. After absorption the skin can be illuminated using a red lamp (conventional PDT) or natural daylight (NDL-PDT) as the absorption spectrum peaks of PpIX are within the visual spectrum of light.

In Finland the approved photosensitizers for PDT are methyl 5-aminolevulinate cream (MAL, Metvix®, Galderma) and aminolevulinic acid gel (BF-200 ALA, Ameluz®, Biofrontera AG). They both have been clinically studied and proved effective in conventional PDT but in NDL-PDT mainly MAL has been in focus of studies. To our knowledge there is only research report concerning the use of BF-200 ALA in NDL-PDT (Neittaanmaki-Perttu et al 2014) which is a study of our own research group. In this study BF-200 ALA appeared to be more effective than MAL.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Daylight Mediated Photodynamic Therapy for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL)
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017


Arm Intervention/treatment
Active Comparator: Actinic keratosis patients
Participant's AKs in facial skin or scalp are first clinically graded and demarcated in two symmetric treatment areas on different sides of face. The areas will be curettaged thinly and next a SPF20 sun protection cream is applied on all sun-exposed areas of the skin. Then a 0,25mm-thick layer of BF-200 ALA (aminolevulinic acid) gel is applied on one treatment side and MAL (methyl 5-aminolevulinate) cream on the other side. The sides will be randomized and the participant doesn't know which side is treated with which light sensitizer. After appropriate absorption time of 30 minutes the patients will be taken to the hospital balcony or yard for 2 hour illumination with natural daylight to accomplish the phototoxic reaction. Maximum dosage of light sensitizer will be 2 grams.
Drug: Aminolevulinic Acid
A 0,25mm-thick layer of BF-200 ALA (aminolevulinic acid, Ameluz®) light sensitizer gel is applied on one randomized treatment side of face.
Other Names:
  • BF-200 ALA
  • Ameluz®
Drug: Methyl 5-aminolevulinate
A 0,25mm-thick layer of MAL (methyl 5-aminolevulinate, Metvix®) light sensitizer cream is applied on one randomized treatment side of face.
Other Names:
  • MAL
  • Metvix®



Primary Outcome Measures :
  1. Clinical healing of actinic keratoses [ Time Frame: 12 months ]
    Participant's AKs in the treatment areas are counted and categorized clinically in three grades I-III (Olsen et al. 1991) before the NDL-PDT treatment. The clinical healing of actinic keratoses will be assessed by a dermatologist 12 months after the treatment.


Secondary Outcome Measures :
  1. Assessing pain experienced by participants: comparing the difference in symmetrical treatment areas of face or scalp [ Time Frame: 1 day ]
    Participants will be asked to fill visual analogue scales (VAS) about pain experienced on both treatment sides of the face or scalp. Pain is assessed during the DL-PDT and after the treatment until the evening.


Other Outcome Measures:
  1. Primary treatment reaction of skin [ Time Frame: 1 week ]
    The participants will come to clinic 5-7 days after treatment and nurse will photograph both treatment sides. Primary treatment reaction of skin will be single-blindedly assessed from the photographs. A dermatologist will assess which side of the face or scalp presents a stronger reaction.

  2. Dermatoecological analyses of the treatment costs [ Time Frame: 12 months ]
    Researchers will analyze the cost-efficacy of the treatments using decision tree, sensitivity analysis, ICER and QALY-analyses to decide with treatment modality is more preferable. The differences in cost-efficacy will most likely depend on the light sensitizer costs and their efficacy on the treated lesions.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with widespread AK lesions symmetrically on face or scalp (at least 3 actinic keratoses symmetrically on face or scalp)
  • AKs of grade I-II

Exclusion Criteria:

  • Thick grade III AKs
  • Previous treatment for actinic keratosis on the same skin area during preceding 6 months
  • Porfyria or solar dermatitis
  • Allergy for photosensitizers used in the study
  • Pregnant or breastfeeding patients
  • Impaired general condition (patient can't manage required 2 hours in sunlight outdoors)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464709


Locations
Finland
Päijät-Häme Central Hospital
Lahti, Finland
Tampere University Hospital
Tampere, Finland
Vaasa Central Hospital
Vaasa, Finland
Sponsors and Collaborators
Joint Authority for Päijät-Häme Social and Health Care
Päijänne Tavastia Central Hospital
Tampere University Hospital
Vaasa Central Hospital, Vaasa, Finland
University of Tampere
STUK - Radiation and Nuclear Safety Authority: Finland
Investigators
Principal Investigator: Janne Rasanen, Lic. Med. Päijänne Tavastia Central Hospital
Study Director: Mari Gronroos, D.Med.Sc. Päijänne Tavastia Central Hospital
Study Chair: Noora Neittaanmaki-Perttu, D.Med.Sc. Helsinki University Central Hospital
Study Chair: Mari Salmivuori, Lic. Med. Päijänne Tavastia Central Hospital
Study Chair: Leea Ylitalo, D.Med.Sc. Tampere University Hospital
Study Chair: Johanna Hagman, D.Med.Sc. Vaasa Central Hospital, Vaasa, Finland
Study Chair: Ida Knutar, Lic. Med. Vaasa Central Hospital, Vaasa, Finland

Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT02464709     History of Changes
Other Study ID Numbers: Q282dnro3/2015
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by Joint Authority for Päijät-Häme Social and Health Care:
Actinic Keratosis
Photodynamic Therapy
Natural Daylight

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Methyl 5-aminolevulinate
Dermatologic Agents