Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00747903|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 8, 2008
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-melanomatous Skin Cancer||Drug: aminolevulinic acid hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Masking:||None (Open Label)|
|Official Title:||Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||December 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00747903
|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 firstname.lastname@example.org|
|OverallOfficial:||Diana Santanello||Laser and Skin Surgery Center of New York|