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Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

Primary Purpose

Non-melanomatous Skin Cancer

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

aminolevulinic acid hydrochloride

About this trial

This is an interventional treatment trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, recurrent skin cancer

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Laser and Skin Surgery Center of New YorkRecruiting

Outcomes

Primary Outcome Measures

Safety

Efficacy

Secondary Outcome Measures

Full Information

NCT ID

NCT00747903

First Posted

September 5, 2008

Last Updated

January 9, 2014

Sponsor

Laser and Skin Surgery Center of New York

1. Study Identification

Unique Protocol Identification Number

NCT00747903

Brief Title

Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

February 2008 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Laser and Skin Surgery Center of New York

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin, recurrent skin cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

aminolevulinic acid hydrochloride

Primary Outcome Measure Information:

Title

Safety

Title

Efficacy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diana Santanello

Organizational Affiliation

Laser and Skin Surgery Center of New York

Facility Information:

Facility Name

Laser and Skin Surgery Center of New York

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roy G. Geronemus, MD

Phone

212-686-7306

mail@laserskinsurgery.com

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer

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