Status:
COMPLETED
Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma (SCC) of the Lip
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
DUSA Pharmaceuticals, Inc.
Conditions:
Actinic Cheilitis
Squamous Cell Carcinoma In-situ (SCC-is)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Our study is designed to evaluate the efficacy of photodynamic therapy (PDT) for treatment of actinic cheilitis (AC) and as an adjunct to Mohs surgery for squamous cell carcinoma (SCC) on the lips. Th...
Detailed Description
BACKGROUND: SCC of the lip is commonly surrounded by extensive AC, which may affect part or all of the lip vermillion. While Mohs surgical technique with complete margin control is the preferred trea...
Eligibility Criteria
Inclusion
- Biopsy proven squamous cell carcinoma of the lip
- Greater than 50% of lip affected by actinic cheilitis by physical exam at time of initial evaluation.
- Patients \> 18 years of age
- Patients must be able to provide informed consent
Exclusion
- Patients with history of photosensitivity
- Patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease
- Patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones)
- Patients with hypersensitivity to porphyrins.
- Women who are pregnant or nursing
- No exclusion based on gender or race
- Patients who have received anti-neoplastic treatment such as imiquimod or 5-FU to the lips within 30 days of enrolling in this study.
- Patients simultaneously participating in another research study for management of SCC or actinic cheilitis
- Subjects that plan to use other forms of AC treatment prior to Mohs.
- Subjects that have an SCC requiring urgent (and sooner) Mohs surgery, including those tumors that are large (\> 2cm or at the discretion of the Principle Investigator) and those subjects that are pregnant or have palpable lymph nodes.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00868088
Start Date
July 1 2009
End Date
September 1 2010
Last Update
July 6 2011
Active Locations (1)
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1
Tufts Medical Center, Department of Dermatology
Boston, Massachusetts, United States, 02111