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Photosensitizer
Photodynamic Therapy for Skin Cancer
Phase 2
Recruiting
Led By Mark S Nestor, MD, PhD
Research Sponsored by The Center for Clinical and Cosmetic Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be an adult (18 years of age or older)
Cannot have other dermatological disease in the SCCis target area
Must not have
Medical laboratory evidence of other non-SCCis tumor in the target lesion biopsy specimen
History of recurrence if the target SCCis lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test the safety and effectiveness of treating early skin cancer cells on the face using a light-sensitive gel and light source. They want to see how much of the cancer cells the treatment can
Who is the study for?
This trial is for individuals with an early stage of skin cancer on the face, known as SCCis. Participants must be willing to attend 14 visits and receive two treatments after giving consent.
What is being tested?
The study tests a light-sensitive gel called Aminolevulinic acid hydrochloride applied to the affected area, followed by exposure to red light. The aim is to see how well it removes or reduces facial skin cancer sections.
What are the potential side effects?
Potential side effects may include reactions at the application site such as redness, pain or burning sensation, itching, and possible scarring. Light sensitivity in treated areas might also occur.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I do not have skin conditions in the area of my skin cancer.
Select...
My facial skin cancer was diagnosed within the last 6 months and is large enough for surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My biopsy shows a non-squamous cell carcinoma tumor.
Select...
My skin cancer has come back in the same place.
Select...
I have a skin condition in the area that needs treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with histological clearance of treated SCCis lesion.
Secondary study objectives
Local Skin Response Scale
Number of participants with clinical clearance of treated SCCis lesion
Size of the lesion
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Photodynamic Therapy (using Red light dose)Experimental Treatment1 Intervention
20 participants will be enrolled to this arm
Find a Location
Who is running the clinical trial?
The Center for Clinical and Cosmetic ResearchLead Sponsor
7 Previous Clinical Trials
317 Total Patients Enrolled
Biofrontera, Inc.UNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Mark S Nestor, MD, PhDPrincipal InvestigatorCenter for Clinical and Cosmetic Research
2 Previous Clinical Trials
52 Total Patients Enrolled