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Photosensitizer

Photodynamic Therapy for Basal Cell Carcinoma

Phase 3

Waitlist Available

Led By David M. Pariser, MD

Research Sponsored by Biofrontera Bioscience GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women ≥18 years of age.

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).

Must not have

Presence of photodermatoses.

Presence and/or physical treatment of skin tumors other than (naïve) 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after the start of the last pdt cycle

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new cancer treatment called photodynamic therapy (PDT) to see if it is safe and effective for treating superficial basal cell carcinoma (BCC).

Who is the study for?

Adults with superficial basal cell carcinoma (sBCC) who can sign consent forms, have a lesion size suitable for treatment without skin grafting, and are willing to avoid certain cosmetics and sun exposure. They must not have hypersensitivity to porphyrins or other exclusion criteria like photodermatoses, coagulation defects, recent use of certain drugs, or unstable medical conditions.

What is being tested?

The trial is testing the effectiveness of Ameluz® with BF-RhodoLED® lamp in treating sBCC compared to a placebo therapy. Participants will undergo up to four PDT sessions within 3.5 months and then have the main target lesion removed for evaluation.

What are the potential side effects?

Potential side effects may include skin reactions at the treatment site such as redness, swelling, pain or burning sensation during illumination; also possible are itching and changes in skin pigmentation after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My skin cancer lesion fits within the treatment light area.

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My skin lesion is larger than 0.6 cm but can be removed without needing a skin graft.

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I don't have tattoos or skin conditions near my cancer that could affect treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skin condition that worsens with light exposure.

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I have not treated skin tumors near my target lesion with surgery or creams recently.

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I do not have any severe health conditions that could affect the study.

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I have skin lesions within a specific area being treated.

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I have tattoos, skin issues, or wounds near my cancer treatment area.

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I have porphyria.

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I have a blood clotting disorder.

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I am currently on medication to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after the start of the last pdt cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after the start of the last pdt cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after the start of the last pdt cycle for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite clinical and histological response of the subject's Main Target Lesion as assessed 12 weeks after the start of the last PDT cycle that included treatment of the Main Target Lesion.

Secondary study objectives

For all Target Lesions, assessment of esthetic appearance by the investigator 12 weeks after the start of the last PDT cycle, but prior to surgical excision of the Main Target Lesion and any alternative treatment of Additional Target Lesions.

Lesion complete clinical response rate per treatment arm (complete clearance of individual lesions (Main and Additional Target Lesions)) according to clinical assessment only, assessed 12 weeks after PDT-1.

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