Status:
COMPLETED
Evaluating the Use of Photodynamic Therapy to Treat Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC)
Lead Sponsor:
The Center for Clinical and Cosmetic Research
Collaborating Sponsors:
Sun Pharmaceutical Industries Limited
Conditions:
Facial Cutaneous Squamous Cell Carcinoma in Situ
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 cream used in combination...
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)
- Voluntary written consent required
- Must have a recently diagnosed (no more than six months from first study visit) facial isSCC lesion that meets surgery excision size requirements
- Cannot have other dermatological disease in the isSCC 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
- If female, cannot be pregnant before and during the study and agree to use acceptable forms of birth control
Exclusion
- Sensitive to any of the study treatment ingredients
- Pregnant or lactating
- Medical laboratory evidence of other non-isSCC tumor in the target lesion biopsy specimen
- History of recurrence in the target isSCC lesion
- Medical laboratory evidence of certain 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 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06159842
Start Date
August 8 2023
End Date
November 13 2024
Last Update
February 12 2025
Active Locations (1)
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1
Center for Clinical and Cosmetic Research
Aventura, Florida, United States, 33180