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

NCT02464709 | Completed Phase 4

• 1 other identifier: Q282dnro3/2015
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Actinic Keratosis; Natural Daylight Photodynamic Therapy

Keywords

Actinic Keratosis; Photodynamic Therapy; Natural Daylight

Outcome Measures

Primary Outcomes (1)

• Clinical healing of actinic keratoses

  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.

  12 months

Secondary Outcomes (1)

• Assessing pain experienced by participants: comparing the difference in symmetrical treatment areas of face or scalp

  1 day

Other Outcomes (2)

• Primary treatment reaction of skin

  1 week

• Dermatoecological analyses of the treatment costs

  12 months

Study Arms (1)

Actinic keratosis patients

EXPERIMENTAL

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; Drug: Methyl 5-aminolevulinate

Interventions

Aminolevulinic Acid DRUG

A 0,25mm-thick layer of BF-200 ALA (aminolevulinic acid, Ameluz®) light sensitizer gel is applied on one randomized treatment side of face.

Also known as: BF-200 ALA, Ameluz®

Actinic keratosis patients

Methyl 5-aminolevulinate DRUG

A 0,25mm-thick layer of MAL (methyl 5-aminolevulinate, Metvix®) light sensitizer cream is applied on one randomized treatment side of face.

Also known as: MAL, Metvix®

Actinic keratosis patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead
• Päijänne Tavastia Central Hospital: collaborator
• Tampere University Hospital: collaborator
• Vaasa Central Hospital, Vaasa, Finland: collaborator
• Tampere University: collaborator
• STUK - Radiation and Nuclear Safety Authority: Finland: collaborator

Study Sites (3)

Päijät-Häme Central Hospital

Lahti, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Vaasa Central Hospital

Vaasa, Finland

Location

Related Publications (1)

• Rasanen JE, Neittaanmaki N, Ylitalo L, Hagman J, Rissanen P, Ylianttila L, Salmivuori M, Snellman E, Gronroos M. 5-aminolaevulinic acid nanoemulsion is more effective than methyl-5-aminolaevulinate in daylight photodynamic therapy for actinic keratosis: a nonsponsored randomized double-blind multicentre trial. Br J Dermatol. 2019 Aug;181(2):265-274. doi: 10.1111/bjd.17311. Epub 2019 Jan 2.

  PMID: 30329163 RESULT

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Aminolevulinic Acid; BF-200 ALA; methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Janne Rasanen, Lic. Med.

  Päijänne Tavastia Central Hospital

  PRINCIPAL INVESTIGATOR

• Mari Gronroos, D.Med.Sc.

  Päijänne Tavastia Central Hospital

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• 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 29, 2015
• First Posted: June 8, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

FI (3)