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Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00747903
First Posted: September 8, 2008
Last Update Posted: January 10, 2014
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention Phase
Non-melanomatous Skin Cancer Drug: aminolevulinic acid hydrochloride Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety
  • Efficacy

Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00747903


Locations
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    mail@laserskinsurgery.com   
Sponsors and Collaborators
Laser and Skin Surgery Center of New York
Investigators
OverallOfficial: Diana Santanello Laser and Skin Surgery Center of New York
  More Information

Responsible Party: Roy G. Geronemus, Laser and Skin Surgery Center of New York
ClinicalTrials.gov Identifier: NCT00747903     History of Changes
Other Study ID Numbers: CDR0000613601
DUSA-PDT-BCC-06
First Submitted: September 5, 2008
First Posted: September 8, 2008
Last Update Posted: January 10, 2014
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
basal cell carcinoma of the skin
recurrent skin cancer

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