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Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma


Phase 2
30 Years
N/A
Open (Enrolling)
Both
Non-Melanomatous Skin Cancer

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Trial Information

Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

Diana Santanello

Investigator Affiliation:

Laser and Skin Surgery Center of New York

Authority:

Unspecified

Study ID:

CDR0000613601

NCT ID:

NCT00747903

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • recurrent skin cancer
  • Skin Neoplasms
  • Carcinoma, Basal Cell

Name

Location

Laser and Skin Surgery Center of New YorkNew York, New York  10016