Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma
30 Years
N/A
Both
Non-Melanomatous Skin Cancer
Trial Information
Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma
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: Patients undergo photodynamic therapy comprising intralesional injection of
aminolevulinic acid followed by non-coherent blue light therapy over approximately 17
minutes. Patients may undergo re-treatment with photodynamic therapy 8 weeks later.
Patients undergo photographic assessment of their skin lesions at baseline, 8 weeks, 16
weeks, and then at 1 and 2 years to evaluate healing time, clinical improvement, and side
effects.
Patients undergo biopsies of their skin lesions at 16 weeks and then at 1 and 2 years to
confirm histological clearance.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety
Safety Issue:
Yes
Principal Investigator
Diana Santanello
Investigator Affiliation:
Laser and Skin Surgery Center of New York
Authority:
Unspecified
Study ID:
CDR0000613601
NCT ID:
NCT00747903
Start Date:
February 2008
Completion Date:
Related Keywords:
- Non-melanomatous Skin Cancer
- basal cell carcinoma of the skin
- recurrent skin cancer
- Skin Neoplasms
- Carcinoma, Basal Cell
Name | Location |
|---|---|
| Laser and Skin Surgery Center of New York | New York, New York 10016 |
