Overview

This trial is active, not recruiting.

Condition basal cell carcinoma (bcc)
Treatments bf-200 ala, methyl-aminolevulinate
Phase phase 3
Sponsor Biofrontera Bioscience GmbH
Collaborator Accovion GmbH
Start date January 2014
End date November 2015
Trial size 277 participants
Trial identifier NCT02144077, 2013-003241-42, ALA-BCC-CT008

Summary

The aim of this study is to test the effectiveness and safety of the medicine Ameluz®, used with photodynamic therapy (PDT), to treat thin, non-aggressive rodent ulcer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(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 0.5 to 1 cm of surrounding margin.
bf-200 ala Ameluz
topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
(Active Comparator)
Topical application of Metvix creme containing 160 mg/g methyl-aminolevulinate. Application of a 1 mm thick layer covering each lesion and 0.5 to 1 cm of surrounding margin.
methyl-aminolevulinate Metvix
topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)

Primary Outcomes

Measure
Patient complete response rate
time frame: 12 weeks after the last PDT

Secondary Outcomes

Measure
Lesion complete response
time frame: 12 weeks after the last PDT
Reduction of lesion area
time frame: 12 weeks after the last PDT
Patient complete response
time frame: 12 weeks after PDT 2
Overall cosmetic outcome
time frame: 12 weeks after the last PDT

Eligibility Criteria

Male or female participants at least 18 years old.

Main Inclusion Criteria: - Willing and able to sign informed consent form; obtained in writing before starting any study procedures - Presence of 1-3 thin (≤2 mm thickness), clinically non-aggressive, primary BCC lesions (primary superficial, nodular, or mixed superficial/nodular) in the face/forehead, bald scalp, extremities and/or neck/trunk. Confirmation of non-aggressiveness and thickness of BCC through biopsies taken at screening for at least one lesion. Lesions non-eligible according to biopsy should timely be removed by surgery or cryotherapy - Diameters of lesions should range between ≥0.5cm and ≤2cm; total maximal treated area is 10cm² (including 0.5-1.0cm margin surrounding each lesion) - Target BCC lesions must be discrete and quantifiable and have to be located within 1-2 treatment areas - Free of significant physical abnormalities (eg tattoos, dermatoses) in potential treatment area that may cause difficulty with examination or final evaluation - Accept to abstain from extensive sunbathing and use of solarium during observer blind part. Patients with sunburn within treatment areas cannot be included until fully recovered - Healthy patients and patients with clinically stable medical conditions, including, but not limited to controlled hypertension, diabetes mellitus type II, hypercholesterolemia, and osteoarthritis, will be permitted to be included in study if their medication is not prohibited by protocol - Women of childbearing potential are permitted to participate in study only if they have a negative serum pregnancy test at screening and willingness to use a highly effective method of contraception during observer blind part Main Exclusion Criteria: - History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA, MAL or any ingredient of Metvix®, including arachis oil, or to peanut or soya - Hypersensitivity to porphyrins - Current treatment with immunosuppression therapy - Presence of porphyria - Presence of BCC lesions on embryonic fusion planes (H-zone) - Presence of more than 3 BCCs - Presence of malignant or benign tumors of the skin other than nonaggressive BCC within the treatment area (eg malignant melanoma, squamous cell carcinoma (SCC), aggressive BCC clinically diagnosed at screening) within the last 12 weeks - Gorlin Syndrome or Xeroderma pigmentosum - Presence of photodermatoses - Treatment of lesions (actinic keratosis (AK), BCC, SCC, Bowens disease, melanoma) ≤12 weeks prior to first PDT, except physical treatments (eg cryosurgery, excision surgery) that will not be allowed ≤6 weeks prior to first PDT (Visit 2). Lesion(s) that seemed eligible clinically which could not be confirmed by biopsy, and which are located ≥10cm to an eligible lesion should timely be removed physically only - Presence of inherited or acquired coagulation defect - Start of intake of medication with hypericin or systemically-acting drugs with phototoxic or photoallergic potential within 8 weeks prior to screening - Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic disease making implementation of protocol or interpretation of study results difficult - Evidence of clinically significant (CS), unstable medical conditions, eg: - Metastatic tumor or tumor with high probability of metastasis - Cardiovascular disease (New York Heart Association [NYHA] class III, IV) - Immunosuppressive condition - Hematologic, hepatic, renal, neurologic, or endocrine condition - Collagen-vascular condition - Gastrointestinal condition - Topical treatment with 5-ALA or MAL outside treatment area during the observer blind part - Any topical treatment including diclofenac and immunomodulatory agents (eg imiquimod, ingenol mebutate) 12 weeks prior to first PDT session and during observer blind part - Any physical treatment during the observer blind part within treated target areas with exception of lesion(s) determined non-eligible by biopsy

Additional Information

Official title A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT)
Principal investigator Rolf M. Szeimies, Prof. Dr.
Description The treatment comprises of up to 2 PDT cycles, each with two PDT sessions one week apart. If 12 weeks after the the second PDT all lesions are completely cleared the patient will enter the follow-up phase. In case of remaining lesions the patient will receive a second PDT cycles starting on the same day.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Biofrontera Bioscience GmbH.