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Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin. Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin. conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin. Clinical research trials and Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin. medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin.. Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin. Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin. clinical trial. Participants oftentimes recieve the finest healthcare available for their Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin. condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin.  Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin.
Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin.
For Condition: Gorlin Syndrome,Nevoid Basal Cell Carcinoma Syndrome,Basal Cell Carcinoma
Status: Terminated
Sponsor(s): QLT Inc , Novartis Pharmaceuticals
Synopsis: The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.
Details: Basal cell carcinoma (BCC) of the skin is the most common type of cancer that can be treated with various therapies including surgical removal. A number of factors can lead to the development of multiple BCC of the skin, including genetic disorders (e.g., nevoid basal cell carcinoma syndrome). Treatment of multiple BCC becomes much more challenging. In these trials, the experimental therapy: verteporfin PDT is compared to placebo PDT. PDT or photodynamic therapy in these studies is the combination of the photoactive drug verteporfin (given intravenously) and red light exposure of skin tumors. The primary objective is to assess whether verteporfin PDT can completely eliminate multiple BCCs. Eligible subjects will have at least 3 BCCs. Study subjects won't know which treatment they have been been assigned to - this is done randomly (like flipping a coin). After study treatment, the BCCs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment. Safety will be assessed by testing blood samples before and after study treatment, and analyzing adverse events and skin reactions to the study treatment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/90 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Currently has at least 3 eligible BCC skin tumors that have never been treated - Is willing to have these tumor sites surgically removed Exclusion Criteria: - Has xeroderma pigmentosum - Has BCC tumors that are the result of prior radiotherapy or immunosuppression due to an organ transplant - Is immunosuppressed - Has abnormal liver function - Is receiving systemic chemotherapy or has received chemotherapy within the last two years
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HermaNeyndorff, Study Director, QLT Inc
Additional Information:
Study ID Numbers: VFI MBCC 01 and VFI MBCC 02;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049959
Other Basal Cell Carcinoma Studies:
1. The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases
2. Aldara™ (Trademark) (Imiquimod) Cream to Treat Basal Cell Carcinoma
3. Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin.
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Two studies to determine if verteporfin PDT is effective & safe in treating multiple basal cell carcinoma of the skin.
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