Safety and Efficacy Study for the Treatment of Non-Aggressive Basal Cell Carcinoma With Photodynamic Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02144077
Recruitment Status : Active, not recruiting
First Posted : May 21, 2014
Last Update Posted : September 29, 2017
Accovion GmbH
Information provided by (Responsible Party):
Biofrontera Bioscience GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma (BCC) Drug: BF-200 ALA Drug: methyl-aminolevulinate Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : January 2014
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: BF-200 ALA
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.
Drug: BF-200 ALA
topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
Other Name: Ameluz

Active Comparator: methyl-aminolevulinate
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.
Drug: methyl-aminolevulinate
topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
Other Name: Metvix

Primary Outcome Measures :
  1. Patient complete response rate [ Time Frame: 12 weeks after the last PDT ]
    Complete responder rate at week 12 after last PDT

Secondary Outcome Measures :
  1. Lesion complete response [ Time Frame: 12 weeks after the last PDT ]
    Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT

  2. Reduction of lesion area [ Time Frame: 12 weeks after the last PDT ]
    Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT.

  3. Patient complete response [ Time Frame: 12 weeks after PDT 2 ]
    Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle).

  4. Overall cosmetic outcome [ Time Frame: 12 weeks after the last PDT ]
    Overall cosmetic outcome 12 weeks after last PDT

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02144077

Klinikum Vest GmbH
Recklinghausen, Westfalen-Lippe, Germany, 45657
Sponsors and Collaborators
Biofrontera Bioscience GmbH
Accovion GmbH
Principal Investigator: Rolf M. Szeimies, Prof. Dr. Klinik fuer Dermatologie und Allergologie (Klinikum Vest - Knappschaftskrankenhaus), Recklinghausen, Germany
Principal Investigator: Colin Morton, Dr. Dermatology Department, Stirling Community Hospital, NHS Forth Valley, United Kingdom

Responsible Party: Biofrontera Bioscience GmbH Identifier: NCT02144077     History of Changes
Other Study ID Numbers: ALA-BCC-CT008
2013-003241-42 ( EudraCT Number )
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017

Keywords provided by Biofrontera Bioscience GmbH:
Photodynamic Therapy
non-aggressive BCC

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Methyl 5-aminolevulinate
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents