Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
Recruitment status was Recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma|
- Safety [ Designated as safety issue: Yes ]
- Efficacy [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- 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.
|United States, New York|
|Laser and Skin Surgery Center of New York||Recruiting|
|New York, New York, United States, 10016|
|Contact: Roy G. Geronemus, MD 212-686-7306 email@example.com|
|Investigator:||Diana Santanello||Laser and Skin Surgery Center of New York|