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Photodynamic Therapy for Skin Cancer
Phase 2
Waitlist Available
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
Cannot have other dermatological disease in the isSCC target area
If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control
Must not have
History of recurrence in the target isSCC lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a cream and light source can safely and effectively treat facial skin cancer. Participants receive 2 treatments over 12 visits.
Who is the study for?
Adults with a recent diagnosis of facial skin cancer (isSCC) that can be treated by surgery are eligible for this trial. Participants must not have other skin conditions in the affected area, agree to follow study rules, and women must not be pregnant or breastfeeding and use birth control.
What is being tested?
The trial is testing a treatment involving a light-sensitive cream applied to the face followed by exposure to blue light. The aim is to see how well it removes early-stage cancer cells from the upper layer of facial skin over two treatments and 12 visits.
What are the potential side effects?
Potential side effects may include reactions at the application site due to sensitivity to ingredients in the cream or light therapy, such as redness, swelling, or discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My skin cancer area does not have any other skin conditions.
Select...
I am not pregnant and agree to use birth control during the study.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My skin cancer has come back in the same spot before.
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 isSCC lesion
Secondary study objectives
Local Skin Response Scale
Number of participants with clinical clearance of treated isSCC 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 (Blue light dose 10 J/cm2 at 10 mW/cm2)Experimental Treatment1 Intervention
30 participants will be enrolled to this arm
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Who is running the clinical trial?
The Center for Clinical and Cosmetic ResearchLead Sponsor
7 Previous Clinical Trials
305 Total Patients Enrolled
Sun Pharmaceutical Industries LimitedIndustry Sponsor
69 Previous Clinical Trials
13,763 Total Patients Enrolled
Mark S Nestor, MD, PhDPrincipal InvestigatorCenter for Clinical and Cosmetic Research
2 Previous Clinical Trials
40 Total Patients Enrolled
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