Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis.

NCT02799082 | Completed Phase 3 Results

• 1 other identifier: ALA-AK-CT003
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with photodynamic therapy (PDT) in patients suffering from actinic keratosis.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (4)

• Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)

  AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).

  12 weeks after the last photodynamic therapy (PDT), up to 24 weeks

• Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)

  AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).

  12 weeks after the last PDT, up to 24 weeks

• Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)

  AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). Analysis was for the subgroup: treated by narrow spectrum lamps only \[n=15 (vehicle), n= 31 (BF-200 ALA)\]

  12 weeks after the last PDT, up to 24 weeks

• Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)

  AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). Analysis was for the subgroup: treated by narrow spectrum lamps only \[n=13 (vehicle), n= 28 (BF-200 ALA)\]

  12 weeks after the last PDT, up to 24 weeks

Secondary Outcomes (11)

• Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT

  12 weeks after the last PDT, up to 24 weeks

• Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT

  12 weeks after the last PDT, up to 24 weeks

• Change in Total Lesion Size 12 Weeks After the Last PDT

  12 weeks after the last PDT, up to 24 weeks

• Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)

  12 weeks after the last PDT, up to 24 weeks

• Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)

  12 weeks after the last PDT, up to 24 weeks

Study Arms (2)

Vehicle

PLACEBO COMPARATOR

Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.

Drug: Vehicle

BF-200 ALA

ACTIVE COMPARATOR

Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.

Drug: BF-200 ALA

Interventions

Vehicle DRUG

topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

Vehicle

BF-200 ALA DRUG

topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).

Also known as: Ameluz

BF-200 ALA

Eligibility Criteria

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

You may qualify if:

• Subjects were willing and able to sign informed consent form.
• Men and women aged between 18 and 85 years inclusive.
• Subjects had a general good and stable health condition as confirmed by a physical examination and by medical history.

You may not qualify if:

• controlled hypertension
• diabetes mellitus type II
• hypercholesterolemia
• osteoarthritis
• Subjects accepted to abstain from sunbathing and the solarium during the study.
• Subjects had at least 4 but not more than 8 clinically confirmed actinic keratosis (AK) target lesions of mild to moderate intensity within the face or bald scalp (excluding eyelids, lips and mucosa), i.e. AK grade I and II according to Olsen et. al. 1991.
• To document and confirm the diagnosis of the investigators:
• Photodocumentation of a representative lesion had to be evaluated and confirmed by an independent expert.
• A pre-study biopsy had to be taken from a second representative AK lesion and was histopathologically evaluated by a dermato-pathological expert.
• If the evaluation of the photo by the independent reviewer could not confirm the diagnosis of the investigator, then the biopsy result decided whether the subject was eligible for the study.
• The AK lesions had to be discrete and quantifiable; the distance from one lesion to its neighbor lesion was greater than 1.0 cm
• The diameter of each AK lesion was not less than 0.5 cm and not greater than 1.5 cm. The size of each baseline AK lesion was recorded by measuring the two largest perpendicular diameters. To describe irregular lesions (ellipsoidal) investigators measured the major and minor axis. Both axes had to be above the minimum of 0.5 cm and less than 1.5 cm.
• The subjects were free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that might cause difficulty with examination or final evaluation.
• The subjects were willing to stop using moisturizers and any other topical treatments with anti-aging products, vitamin A, vitamin C, and/or vitamin E containing ointments and creams, and green tea preparations during the study within the treatment area. Sunscreens were allowed, but were not to be applied in the treatment area within approximately 24 hours before a clinical visit with lesion count.
• Women of childbearing potential were only allowed to participate in this study, if they used a highly effective method of contraception and had a negative serum pregnancy test.

Sponsors & Collaborators

• Biofrontera Bioscience GmbH: lead

Related Publications (2)

• Szeimies RM, Radny P, Sebastian M, Borrosch F, Dirschka T, Krahn-Senftleben G, Reich K, Pabst G, Voss D, Foguet M, Gahlmann R, Lubbert H, Reinhold U. Photodynamic therapy with BF-200 ALA for the treatment of actinic keratosis: results of a prospective, randomized, double-blind, placebo-controlled phase III study. Br J Dermatol. 2010 Aug;163(2):386-94. doi: 10.1111/j.1365-2133.2010.09873.x. Epub 2010 May 28.

  PMID: 20518784 RESULT

• 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 RESULT

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

BF-200 ALA; Aminolevulinic Acid

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

• Rolf-Markus Szeimies, Prof Dr

  Klinikum der Universität Regensburg Klinik und Poliklinik für Dermatologie

  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: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 14, 2016
• Study Start: December 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 6, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share