Photodynamic Therapy for Basal Cell Carcinoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but certain medications are restricted. You cannot start new medications with phototoxic or photoallergic potential, and some systemic treatments like immunosuppressive therapies and corticosteroids must be stopped for a specific period before and during the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the treatment BF-200 ALA (Ameluz®) for basal cell carcinoma?
Research shows that 5-aminolevulinic acid (5-ALA), a component of BF-200 ALA, is effective in treating basal cell carcinomas (BCCs) when used in photodynamic therapy (PDT). Studies indicate that 5-ALA in various forms, such as nanoemulsions and patches, has shown promising results in achieving complete response in superficial BCCs.12345
Is photodynamic therapy with BF-200 ALA safe for treating basal cell carcinoma?
Research indicates that photodynamic therapy using BF-200 ALA (Ameluz) is generally safe for treating basal cell carcinoma, with only minor and temporary skin reactions at the application site. Studies show that the treatment is well-tolerated, with minimal systemic absorption of the active ingredient.24567
How is the treatment BF-200 ALA (Ameluz®) different from other treatments for basal cell carcinoma?
What is the purpose of this trial?
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).
Research Team
David M. Pariser
Principal Investigator
Virginia Clinical Research, Inc.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive photodynamic therapy (PDT) with BF-200 ALA or placebo, consisting of up to two PDT cycles with two sessions each, one to two weeks apart.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on clinical and histological clearance of lesions.
Treatment Details
Interventions
- BF-200 ALA (Ameluz®)
BF-200 ALA (Ameluz®) is already approved in European Union, United Kingdom, United States for the following indications:
- Actinic keratosis of mild to moderate intensity on the face and scalp
- Actinic keratosis on extremities and trunk/neck
- Actinic keratosis of mild to moderate intensity on the face and scalp
- Actinic keratosis on extremities and trunk/neck
- Actinic keratosis of mild to moderate severity on the face and scalp
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biofrontera Bioscience GmbH
Lead Sponsor