This Study Aims to Evaluate the Safety and Efficacy of BF-200 ALA for the Treatment of Actinic Keratosis With Photodynamic Therapy (PDT)

Actinic Keratosis Clinical Trial

Official title:

A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of a Nanoemulsion Gel Formulation BF-200 ALA, in Comparison With Metvix® and Placebo, for the Treatment of Actinic Keratosis With PDT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799069
• Other study ID #: ALA-AK-CT002
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2016
• Last updated: June 9, 2016
• Start date: April 2008
• Est. completion date: August 2009

Study information

• Verified date: June 2016
• Source: Biofrontera Bioscience GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Austrian Medicines and Medical Devices AgencySwitzerland: SwissmedicFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

Description:

This was a randomized, observer-blind, multinational, comparator and placebo-controlled parallel group, (3:3:1 ratio) study to compare the efficacy and safety of BF-200 ALA with the comparator Metvix® (methyl-[5-amino-4-oxopentanoate]) and placebo, for the treatment of AK with PDT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Main Inclusion Criteria:

• Written informed consent.

• Men and women between 18 and 85 years of age.

• 4-8 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.

• Healthy subjects and subjects with clinically stable medical conditions including, but not limited to the following diseases (controlled hypertension, diabetes mellitus type II, hypercholesterolemia, osteoarthritis) were permitted to be included in the study if the medication taken for the treatment of the disease did not match an exclusion criterion or was not specified as prohibited concomitant medication.

• No extensive sunbathing or solarium use during the trial.

• Negative pregnancy test at screening.

Main exclusion criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• BF-200 ALA
topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.
• MAL
topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Biofrontera Bioscience GmbH	Accovion GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall subject complete response	An overall complete responder was defined as a subject in whom all treated lesions were cleared 12 weeks after either the first PDT or re-treatment.	12 weeks after the last photodynamic therapy (PDT)	No
Secondary	Subject complete response (complete clearance of all treated lesions) at each assessment.	An overall complete responder was defined as a subject in whom all treated lesions were cleared at separate assessment time points: 3-4 weeks after the first PDT; 12 weeks after the first PDT; 3-4 weeks after second; 12 weeks after the second PDT; 3-4 weeks after the last PDT	up to 8 weeks after the last PDT	No
Secondary	subject partial response	complete clearance of at least 75% of the treated lesions) at each assessment.	up to 12 weeks after the last PDT	No
Secondary	complete response of lesions	completely cleared individual lesions at each assessment	up to 12 weeks after the last PDT	No
Secondary	reduction in total lesion area	the total size of all treated lesions per subject assessed at each assessment and compared to the lesion area at baseline.	up to 12 weeks after the last PDT	No
Secondary	overall cosmetic outcome of the treated skin	overall cosmetic outcome 12 weeks after the last PDT. The cosmetic outcome at the end-of-study visit will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy. The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) at a given visit has improved by at least 2 points as compared to baseline; the cosmetic outcome is rated as good if the sum score at a given visit has improved by at least 1 point as compared to baseline; the cosmetic outcome is rated as satisfactory if the sum score at a given visit is identical to the one at baseline; the cosmetic outcome is rated as unsatisfactory if the sum score at a given visit has worsened by 1 point compared to baseline, the cosmetic outcome is rated as impaired if the sum score at a given visit has worsened by at least 2 points compared to baseline.	12 weeks after the last PDT	No
Secondary	Local skin reactions	Local skin reactions in the treatment area as assessed by the investigator	during and after PDT treatment [3 h - 4 h ]	Yes
Secondary	Local discomfort	Local discomfort and pain reported by the patients during illumination	during and after PDT treatment [3 h - 4 h ]	Yes
Secondary	related Adverse events (AEs)	Frequency and extent of related treatment - emerged adverse events (TEAEs) with the randomized investigational medicinal product	up to 12 weeks after the last PDT	Yes