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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

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 below
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I am 18 years old or older.
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I do not have skin conditions in the area of my skin cancer.
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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:
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My biopsy shows a non-squamous cell carcinoma tumor.
Select...
My skin cancer has come back in the same place.
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I have a skin condition in the area that needs treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

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

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT02075671
10%
Contact Dermatitis
10%
Post-Treatment Erythema
10%
Hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levulan and Blu-U Light
Vehicle and Blu-U Light
Vehicle Only

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
~13 spots leftby Aug 2025
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