Status:
UNKNOWN
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
Lead Sponsor:
Laser and Skin Surgery Center of New York
Conditions:
Non-melanomatous Skin Cancer
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment again...
Detailed Description
OBJECTIVES: * To determine the safety and efficacy of intralesional photodynamic therapy using aminolevulinic acid and non-coherent blue light in patients with nodular basal cell carcinoma. OUTLINE:...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Biopsy-proven basal cell carcinoma on the trunk or extremities
- Tumor size ≤ 2 cm in diameter
- PATIENT CHARACTERISTICS:
- Willing and able to comply with all follow-up requirements
- Mentally competent
- No active, localized, or systemic infections
- Not immunocompromised
- No coagulation disorder
- No photosensitivity or allergy to sunlight
- Not pregnant or nursing
- No history of keloid formation
- No history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis
- PRIOR CONCURRENT THERAPY:
- No prior gold therapy
- No prior radiotherapy to the trunk and extremities
- More than 24 months since prior oral retinoids (e.g., isotretinoin or acitretin) or photosensitizing drugs (e.g., Declomycin®)
- More than 1 year since prior collagen or other injections, Botox® injections, chemical peels, dermabrasion, or resurfacing procedures
- More than 1 month since prior topical retinoid therapy
- No concurrent aspirin or antioxidants
- No concurrent anticoagulation medications
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00747903
Start Date
February 1 2008
Last Update
January 10 2014
Active Locations (1)
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1
Laser and Skin Surgery Center of New York
New York, New York, United States, 10016