Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
- Conditions
- Non-melanomatous Skin Cancer
- Registration Number
- NCT00747903
- Lead Sponsor
- Laser and Skin Surgery Center of New York
- 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 against skin cancer.
PURPOSE: This phase II trial is studying the side effects of photodynamic therapy using aminolevulinic acid and to see how well it works in treating patients with skin cancer.
- 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: 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Safety
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Laser and Skin Surgery Center of New York
🇺🇸New York, New York, United States
Laser and Skin Surgery Center of New York🇺🇸New York, New York, United StatesRoy G. Geronemus, MDContact212-686-7306mail@laserskinsurgery.com