Photodynamic Therapy to Treat Actinic Damage in Patients With Squamous Cell Carcinoma (SCC) of the Lip
Completed · Phase 4 · Has a placebo group
Conditions studied: Actinic Cheilitis, Squamous Cell Carcinoma In-situ (SCC-is), Squamous Cell Carcinoma (SCC), Photodynamic Therapy (PDT), Mohs Surgery
In brief
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. This study will utilize an FDA approved PDT modality (DUSA, Inc., Wilmington, MA 01887) using topical 5-amino-levulinic acid (ALA) for photosensitization followed by exposure to a Blu-U light source emitting 405-420nm wavelength light.
Key facts
- Study ID
- NCT00868088
- Run by
- Tufts Medical Center
- People needed
- 34
- Starts
- 2009-07-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2011-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Tufts Medical Center, Department of Dermatology — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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