Photodynamic Therapy 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. Identifier: NCT00002963
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 31, 2013
Information provided by:
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be effective in treating patients with skin cancer.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in treating patients with skin cancer.

Condition or disease Intervention/treatment Phase
Non-melanomatous Skin Cancer Drug: aminolevulinic acid hydrochloride Procedure: conventional surgery Phase 2

Detailed Description:


  • Characterize the penetration of topically applied aminolevulinic acid (ALA) into the lesions of patients with primary basal cell and squamous cell carcinomas.
  • Quantitate the depth of fluorescence achievable with varying application periods of ALA in these patients.
  • Compare the results of tissue fluorescence with surface fluorescence measurements in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma (BCC) vs nodular BCC vs squamous cell carcinoma). Patients within each group are randomized to receive one of two application times: 4-5 or 20-24 hours in duration.

Aminolevulinic acid is topically applied either in a cream mixture or an alcohol base and an occlusive dressing placed over the lesion. After the randomized treatment duration has expired, the dressing is removed and quantitative protoporphyrin IX fluorescence measurements from the tumor and surrounding skin are mapped using a fluorometer. Routine surgical excision is then performed on the carcinoma.

Patients return after one to two weeks for a follow-up examination and suture removal.

PROJECTED ACCRUAL: 54 patients will be accrued within 10 years.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Cutaneous Absorption and Intralesional Penetration of Topical Amino-Levulinic Acid in Basal Cell Carcinoma and Squamous Cell Carcinoma as Measured by In Situ Fluorescence and Intensified Video Fluorescence Microscopy
Study Start Date : November 1993
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Depth of penetration of aminolevulinic acid as measured by the accumulation of protoporphyrin IX

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically proven basal cell carcinoma or squamous cell carcinoma
  • Candidate for complete surgical excision



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No inflammation or infection of treated area


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Biopsy at least 2 weeks prior to surgery

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002963

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Study Chair: Allan R. Oseroff, MD, PhD Roswell Park Cancer Institute Identifier: NCT00002963     History of Changes
Other Study ID Numbers: DS 92-42
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Roswell Park Cancer Institute:
basal cell carcinoma of the skin
squamous cell carcinoma of the skin

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents