Recruiting
Phase 2

Photodynamic Therapy

Sponsor:

Laser and Skin Surgery Center of New York

Code:

NCT00747903

Conditions

Non-melanomatous Skin Cancer

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

Interventions

aminolevulinic acid hydrochloride

Study Details

Brief summary:

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.

Conditions

Non-melanomatous Skin Cancer

Study ID

NCT00747903

Start date

Feb, 2008

Status verified date

Jul, 2009

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

aminolevulinic acid hydrochloride

Primary outcome measure

  • Safety [ Time Frame: undefined ]
  • Efficacy [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Laser and Skin Surgery Center of New York

Recruiting

New York, New York, United States, 10016

Contacts

Roy G. Geronemus, MD

212-686-7306mail@laserskinsurgery.com

More Information

Sponsor

Laser and Skin Surgery Center of New York

Last update posted

Jan 10, 2014

Last verified

Jul, 2009

Keywords

  • basal cell carcinoma of the skin
  • recurrent skin cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laser and Skin Surgery Center of New York on 2014-01-10.