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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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after the start of the last pdt cycle
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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.
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 the start of the last PDT cycle.
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BF-200 ALAExperimental Treatment1 Intervention
Topical application of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid).
Photodynamic therapy (PDT)
Group II: VehiclePlacebo Group1 Intervention
Topical application of vehicle to BF-200 ALA containing no active ingredient. Photodynamic therapy (PDT)
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Who is running the clinical trial?
Biofrontera Bioscience GmbHLead Sponsor
10 Previous Clinical Trials
1,625 Total Patients Enrolled
David M. Pariser, MDPrincipal InvestigatorVirginia Clinical Research, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a skin condition that worsens with light exposure.I am 18 years old or older.I have not treated skin tumors near my target lesion with surgery or creams recently.I am willing and able to sign the consent and HIPAA forms for this study.My skin cancer lesion fits within the treatment light area.If a nearby lesion is not suitable for the study, my eligible lesion must be excluded if it's within 5 cm.I haven't used any skin treatments for cancer except for the study treatment in the last 12 weeks.I haven't used any skin treatments except for corticosteroids and NSAIDs in the last 12 weeks.I have at least one new skin lesion likely to be basal cell carcinoma not previously treated or in sensitive areas.My skin lesion is larger than 0.6 cm but can be removed without needing a skin graft.I don't have tattoos or skin conditions near my cancer that could affect treatment.I agree not to sunbathe or use tanning beds during the study.I am healthy or have stable conditions like high blood pressure or type 2 diabetes.I do not have any severe health conditions that could affect the study.I have skin lesions within a specific area being treated.I have tattoos, skin issues, or wounds near my cancer treatment area.I am willing to undergo up to 4 treatments and possibly have a lesion removed within 3.5 months.You are allergic to porphyrins.I have porphyria.I have a blood clotting disorder.I agree not to use cosmetics or moisturizers near my treatment area before and after PDT sessions.I am currently on medication to suppress my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: BF-200 ALA
- Group 2: Vehicle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) for use?
"There is some efficacy data to support the use of photodynamic therapy in this phase 3 trial, as well as multiple rounds of data to support its safety."
Answered by AI
What types of conditions or diseases does Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) commonly address?
"Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), which is commonly used to treat scalp structure, can also be used to address other issues like squamous cell carcinoma and face cancer."
Answered by AI
Are there still opportunities available for people to participate in this trial?
"The trial is presently looking for subjects, as seen on clinicaltrials.gov. This information is accurate as of 2/9/2022, and the trial was originally posted on 9/25/2018."
Answered by AI
Could you please list other published research on Photodynamic therapy (PDT) using ALA or Ameluz?
"First researched in 2013 at Tel Aviv sourasky medical center, photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT) has thus far had 52 completed clinical trials. Currently, 20 more trials are underway with several of these based in West Jordan, Utah."
Answered by AI
Does this research project have a large number of sites in urban areas?
"Currently, this trial has 18 enrollees from various locations including Jordan Valley Dermatology in West Jordan, Clinical Research Center of the Carolinas in Charleston, and First OC Dermatology in Fountain Valley."
Answered by AI
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