Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz ) and BF-RhodoLED in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).

  • STATUS
    Recruiting
  • End date
    Feb 20, 2026
  • participants needed
    186
  • sponsor
    Biofrontera Bioscience GmbH
Updated on 22 September 2021

Summary

The aim of this study is to test the safety and efficacy of photodynamic therapy (PDT) with the medication Ameluz performed with the PDT-lamp BF-RhodoLED in comparison to the respective placebo treatment for superficial basal cell carcinoma (BCC).

Description

The study will be conducted as randomized, double blind and vehicle-controlled ( 4:1 ratio of verum (BF-200 ALA; Ameluz) to vehicle (placebo)) clinical trial at 15 sites in the United States of America (US). Each site should randomize between 10 and 20 subjects.

Each subject will complete a clinical observation period that will last for up to 7 months (up to 4 weeks screening and pre-randomization period, and up to 6 months clinical observation period) followed by a 5-year follow-up (FU) period after the completion of the first PDT cycle.

The treatment of superficial BCC lesion(s) comprises of up to two PDT cycles each with two PDT sessions one to two weeks apart of each other. 12 weeks after the first PDT of the first cycle lesion(s) will be assessed clinically and only subjects with remaining BCC lesion(s) will be retreated in the second PDT cycle starting the same day. For clinically completely cleared subjects the clinical observation period of the study will end and these subjects will enter the FU part of the study.

For each subject a Main Target Lesion will be defined that will be excised either 12 weeks after the first PDT of the first cycle, if clinically cleared, or at the end of the clinical observation period in order to histologically confirm the clinical assessment. Additional Target Lesions will be assessed clinically, only. Randomization will be stratified by the number of lesions (1 vs 2 Lesion(s)).

Definitions of complete responders comprise of:

  1. Complete response of the Main Target Lesion which is assessed 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion and is defined as a Main Target Lesion that is completely clinically and histologically cleared.
  2. In general, clinically complete responders are categorized 12 weeks after the start of the last PDT cycle according to clinical assessment only and are defined as subjects with all lesions (Main plus Additional Target Lesions) clinically cleared.

Verum and vehicle are indistinguishable. However, treatment is accompanied with typical adverse events (AEs). In order to guarantee the blind status of the investigator assessing efficacy after each PDT cycle, a second investigator or delegated person will perform drug application and light treatment as well as all safety evaluations at visits where PDT is applied and during the phone call 1 week after each PDT cycle, respectively. Both investigators (delegated person(s)) are not entitled to exchange information about the study outcome and side effects.

Details
Condition Superficial Basal Cell Carcinoma
Treatment Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
Clinical Study IdentifierNCT03573401
SponsorBiofrontera Bioscience GmbH
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Willingness and ability to sign the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent form and a HIPAA form must be obtained in writing for all subjects prior to starting any study procedures
Men or women 18 years of age
Presence of 1 nave sBCC lesion in the treatment areas face/forehead, bald scalp, extremities and/or neck/trunk, all of which are, according to the clinical judgement of the investigator, likely to be histologically confirmed as sBCCs. Lesions should not be within the embryonic fusion planes (H-zone), especially within 2 cm of the hair zone or on the ears. In case of multiple lesions, one lesion is defined as Main Target Lesion which will be excised at the end of the clinical observation period. Only eligible nave sBCCs, confirmed by histology taken at screening, are allowed to be included in the study as Main or Additional Target Lesions. Thus, eligible sBCCs must lack any histological evidence of aggressive growth patterns (e.g. severe squamous metaplasia, infiltrative/desmoplastic features or basosquamous features). BCCs assessed as non-nave (e.g. previously treated or recurrent) or non-eligible by biopsy taken at screening (and in a distance >5 cm from the next lesion included in the study) should be excised by surgery or removed by cryotherapy in a timely manner. Other treatments for these lesions are not allowed during the study
The diameter of each eligible lesion should be 0.6 cm, and the entire treatment field must not exceed ~20 cm. The treatment field is defined as the field to which IMP is applied, usually including the target lesions and margins surrounding the lesions of up to 1 cm. For the Main Target Lesion, the maximal lesion size should be such that surgical excision without a skin transplant is feasible according to the investigator's judgement
Target BCC lesions must be discrete and located within 1-2 illumination areas (the illumination area is defined by the effective illumination area of the BF-RhodoLED device with approximately 6 x 16 cm)
Willingness to receive up to 4 PDTs within 3.5 months and excision of the Main Target Lesion either at Visit 5, if clinically cleared, or at the end of the clinical observation period 12 weeks after the start of the last PDT cycle (Visit 8), irrespective of whether the treated Main Target Lesion was clinically cleared or not
Free of significant physical abnormalities (e.g. tattoos, dermatoses) within the potential treatment field plus a 5 cm radius surrounding the target lesion(s) as they may interfere with examination or final evaluation
Willingness to stop the use of moisturizers and any other cosmetics within the treatment field plus a 5 cm radius surrounding the target lesion(s) 48 hours prior to an office visit and 48 hours after each PDT session. Sunscreen will be allowed, but should not be applied to the treatment field plus the 5 cm radius surrounding the target lesion(s) within approximately 24 h prior to a clinical visit
Acceptance to abstain from extensive sunbathing and the use of a solarium during the clinical observation period. Subjects with sunburn within treatment areas cannot be included until fully recovered
Healthy subjects and subjects 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 the study if their medication is not prohibited by this protocol
Women of childbearing potential are permitted to participate in this study only if they have a negative serum pregnancy test at screening and are willing to use a highly effective method of contraception during the clinical observation period of the study

Exclusion Criteria

History of hypersensitivity to 5-ALA or any ingredient of BF-200 ALA which includes soybean phosphatidylcholine
Hypersensitivity to porphyrins
Current treatment with immunosuppression therapy
Presence of photodermatoses
Presence of porphyria
Presence of clinically significant inherited or acquired coagulation defect
Evidence of clinically significant (CS) unstable medical conditions, such as
Metastatic tumor or tumor with high probability of metastasis
Cardiovascular disease class III, IV (New York Heart Association [NYHA])
Immunosuppressive condition
Hematologic, hepatic, renal, neurologic, or endocrine condition
Collagen-vascular condition
Gastrointestinal condition
Clinically relevant cardiovascular, hepatic, renal, neurologic, endocrine, or other major systemic diseases that complicate implementation of the protocol or interpretation of the study results
Gorlin Syndrome or Xeroderma pigmentosum
Presence and/or physical treatment of skin tumors other than (nave) sBCC (e.g. malignant melanoma, squamous cell carcinoma (SCC), Bowen's disease, aggressive BCC or nBCC diagnosed at the screening visit by clinical assessment) within a distance of 5 cm from the nearest target lesion within 4 weeks prior to PDT (Visit 2) until the end of the clinical observation period. However, biopsied lesion(s) that were not confirmed eligible at screening and which are located at a distance of > 5 cm from any lesion(s) that will be included in the study can be surgically removed. Treatment by PDT or topical medication during the course of the clinical observation period of the study triggers exclusion of the subject
If lesion(s) are assessed as non-eligible by biopsy during initial screening and these lesions are localized within a distance of 5 cm from an otherwise suitable lesion, this suitable lesion must be excluded from the study
ny AK lesions within the treatment field (lesion area including margin of 0.5 to 1.0 cm)
Any topical medical treatment of AK, other non-melanoma skin cancers (NMSC), or melanoma (except for IMP treatment of the target lesion(s)) starting 12 weeks prior to Visit 2 (PDT-1) and lasting until the end of the clinical observation period
Any other topical medical treatment of the skin 12 weeks prior to Visit 2 (PDT-1) until the end of the clinical observation period, with the exception of
Topical treatments with corticosteroids (allowed throughout the clinical observation period of the study)
Topical non-steroidal anti-inflammatory drugs (NSAIDs such as diclofenac) (allowed throughout the clinical observation period of the study with the restriction of 7 days prior to and 7 days after PDTs)
Start of intake of medication with hypericin or systemically acting drugs with phototoxic or photoallergic potential within 8 weeks prior to screening
Any of the systemic treatments listed below, within the designated period prior to PDT and during the clinical observation period
Interferon - 6 weeks
Immunomodulators or immunosuppressive therapies - 12 weeks
Cytotoxic drugs - 6 months
Investigational drugs - 8 weeks
Drugs known to have major organ toxicity - 8 weeks
Corticosteroids (oral or injectable) - 6 weeks
MAL or ALA - 12 weeks
Systemic treatment with NSAIDs is not to be used 7 days prior to and 7 days after PDT. ASA (e.g. Aspirin) up to 100 mg/ day, ibuprofen up to 200 mg/ day, and acetaminophen (e.g. Tylenol) is allowed during this period
Presence of tattoos, skin inflammation, wounds, etc. in the treatment field(s) plus a 5 cm radius surrounding the target lesion(s)
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