This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 5, 2008
Last updated: January 9, 2014
Last verified: July 2009

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:


  • 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.


Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Biopsy-proven basal cell carcinoma on the trunk or extremities

    • Tumor size ≤ 2 cm in diameter


  • 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


  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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   
Sponsors and Collaborators
Laser and Skin Surgery Center of New York
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 Identifier: NCT00747903     History of Changes
Other Study ID Numbers: CDR0000613601
Study First Received: September 5, 2008
Last Updated: January 9, 2014

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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents processed this record on September 21, 2017