Evaluation of Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy

NCT02799069 | Completed Phase 3 Results

• 1 other identifier: ALA-AK-CT002
• Study Type: interventional
• Target: 571
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the non-inferiority of BF-200 ALA (Ameluz) in the treatment of actinic keratosis (AK) with photodynamic therapy (PDT) compared to Metvix.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT

  An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)

  12 weeks after the last PDT, up to 24 weeks after the first treatment

• Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP

  An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)

  12 weeks after the last PDT, up to 24 weeks after the first treatment

• Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only

  Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (\~630 nm). An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT. The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)

  12 weeks after the last PDT, up to 24 weeks after the first treatment

Secondary Outcomes (32)

• Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT)

  3-4 weeks after the first PDT

• Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT)

  12 weeks after the first PDT

• Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT)

  3-4 weeks after the second PDT, 15-16 weeks after first treatment

• Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT)

  12 weeks after the second PDT, 24 weeks after first treatment

• Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT)

  3-4 weeks after the last PDT, up to 16 weeks after the first treatment

Study Arms (3)

BF-200 ALA

ACTIVE COMPARATOR

Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.

Drug: BF-200 ALA

MAL Cream

ACTIVE COMPARATOR

Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.

Drug: MAL Cream

Vehicle

PLACEBO COMPARATOR

Topical application of matched Placebo to BF-200 ALA gel (without containing active ingredient) ). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.

Drug: Vehicle

Interventions

BF-200 ALA DRUG

topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.

Also known as: Ameluz

BF-200 ALA

MAL Cream DRUG

topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.

Also known as: Metvix, Metvixia

MAL Cream

Vehicle DRUG

topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.

Also known as: matched placebo to BF-200 ALA gel

Vehicle

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Men and women between 18 and 85 years of age.
• AK lesions of 0.5 to 1.5 cm diameter of mild to moderate intensity (Olsen grade 1 and 2) in the face and/or on the bald scalp. Lesions on the eyes, nostrils, ears and mouth were not considered for treatment during the planned study.
• Target AK lesions were to be discrete and quantifiable; adjacent AK lesions were to show a minimum distance of 1.0 cm from one another.
• Confirmation of AK by biopsy taken at screening.
• Free of significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment region that could have caused difficulty with examination or final evaluation.
• Willingness to stop the use of moisturizers and any other topical treatments within the treatment region.
• Good general health condition.
• No extensive sunbathing or solarium use during the trial.
• Negative pregnancy test at screening.

You may not qualify if:

• Known hypersensitivity to BF-200 ALA, MAL (methyl-aminolevulinic acid) and/or any of the ingredients of the formulations
• Clinically significant medical conditions (tumor disease etc.) making implementation of the protocol or interpretation of the study results difficult
• Presence of photodermatoses
• Presence of other tumors in the treatment areas within the last 4 weeks
• Start of treatment with phototoxic or photoallergic drugs within 8 weeks prior to screening
• Current treatment with immunosuppression therapy
• Hypersensitivity to porphyrins
• Presence of porphyria
• Presence of inherited or acquired coagulation defect
• Any topical treatment within the treatment area within 12 weeks before PDT1 (first PDT Treatment)
• Topical treatment with ALA or MAL outside the treatment area during participation in the study
• None of the specified systemic treatments within the designated period before PDT1

Sponsors & Collaborators

• Biofrontera Bioscience GmbH: lead
• Accovion GmbH: collaborator

Related Publications (2)

• Dirschka T, Radny P, Dominicus R, Mensing H, Bruning H, Jenne L, Karl L, Sebastian M, Oster-Schmidt C, Klovekorn W, Reinhold U, Tanner M, Grone D, Deichmann M, Simon M, Hubinger F, Hofbauer G, Krahn-Senftleben G, Borrosch F, Reich K, Berking C, Wolf P, Lehmann P, Moers-Carpi M, Honigsmann H, Wernicke-Panten K, Helwig C, Foguet M, Schmitz B, Lubbert H, Szeimies RM; AK-CT002 Study Group. Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a multicentre, randomized, observer-blind phase III study in comparison with a registered methyl-5-aminolaevulinate cream and placebo. Br J Dermatol. 2012 Jan;166(1):137-46. doi: 10.1111/j.1365-2133.2011.10613.x. Epub 2011 Dec 21.

  PMID: 21910711 BACKGROUND

• Dirschka T, Radny P, Dominicus R, Mensing H, Bruning H, Jenne L, Karl L, Sebastian M, Oster-Schmidt C, Klovekorn W, Reinhold U, Tanner M, Grone D, Deichmann M, Simon M, Hubinger F, Hofbauer G, Krahn-Senftleben G, Borrosch F, Reich K, Berking C, Wolf P, Lehmann P, Moers-Carpi M, Honigsmann H, Wernicke-Panten K, Hahn S, Pabst G, Voss D, Foguet M, Schmitz B, Lubbert H, Szeimies RM; AK-CT002 Study Group; AK-CT003 Study Group. Long-term (6 and 12 months) follow-up of two prospective, randomized, controlled phase III trials of photodynamic therapy with BF-200 ALA and methyl aminolaevulinate for the treatment of actinic keratosis. Br J Dermatol. 2013 Apr;168(4):825-36. doi: 10.1111/bjd.12158.

  PMID: 23252768 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

BF-200 ALA; Aminolevulinic Acid; 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

Results Point of Contact

• Title: Dr. Beate Schmitz
• Organization: Biofrontera Bioscience GmbH

b.schmitz@biofrontera.com

+49 214 876 32

Study Officials

• Thomas Dirschka, Prof. Dr.

  Akademische Lehrpraxis der Universität Witten-Herdecke Heinz-Fangman-Straße 57 42287 Wuppertal

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 14, 2016
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 28, 2017
• Results First Posted: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share