NCT00747903

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

January 10, 2014

Status Verified

July 1, 2009

Enrollment Period

2.8 years

First QC Date

September 5, 2008

Last Update Submit

January 9, 2014

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skinrecurrent skin cancer

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Efficacy

Interventions

aminolevulinic acid hydrochlorideDRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Laser and Skin Surgery Center of New York

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Basal CellSkin Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Diana Santanello

    Laser and Skin Surgery Center of New York

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2010

Last Updated

January 10, 2014

Record last verified: 2009-07

Locations

US(1)