Status:
RECRUITING
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (SCCis)
Lead Sponsor:
The Center for Clinical and Cosmetic Research
Collaborating Sponsors:
Biofrontera Inc.
Conditions:
Cutaneous Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to test how safe and effective it is to treat early form of cancer cells found in the upper skin layer of the face, using a light-sensitive gel used in combination w...
Detailed Description
In the study, participants will be asked to complete the following: * Provide basic personal information (including date of birth, gender, race and ethnicity) * Provide their medical/ surgical histor...
Eligibility Criteria
Inclusion
- Must be an adult (18 years of age or older)
- Must have a recently diagnosed (no more than six months from first study visit) facial SCCis lesion that meets surgery excision size requirements
- Cannot have other dermatological disease in the SCCis target area
- Must be willing to follow study instructions and complete study requirements, including not using non-approved lotions and creams on the treatments areas
- Voluntary written consent required
- Allow photographs of the area of skin cancer being treated on the face
- Agree to use acceptable forms of birth control. If female, cannot be pregnant before and during the study
Exclusion
- Pregnant or lactating
- Sensitive to any of the study treatment ingredients
- Medical laboratory evidence of other non-SCCis tumor in the target lesion biopsy specimen
- History of recurrence if the target SCCis lesion
- Evidence of dermatological disease or skin condition in the treatment area
- Medical laboratory evidence of growth patterns in the target lesion biopsy specimen
- Chronic medical condition that in the Investigators opinion will interfere in the trial or affect participant safety.
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06577311
Start Date
August 14 2024
End Date
August 1 2025
Last Update
August 29 2024
Active Locations (1)
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1
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180