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A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus Clinical research trials and A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus health trials occur in hundreds of cities throughout 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus. A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus  A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus
A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus
For Condition: Discoid Lupus Erythematosus
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The purpose of this double-masked, pilot trial is to determine whether 20 percent thalidomide ointment is safe and effective for the treatment of chronic discoid lupus erythematosus (CDLE) when used under an occlusive dressing. Seventeen patients with two similar lesions will have lesions randomized to receive either intervention or placebo therapy.
Details: The purpose of this double-masked, pilot trial is to determine whether 20 % thalidomide ointment is safe and effective for the treatment of chronic discoid lupus erythematosus (CDLE) when used under an occlusive dressing. Seventeen patients with two similar lesions will have lesions randomized to receive either intervention or placebo therapy.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Age, 18 or more. Must have lesions that fulfill clinical and histologic criteria for active CDLE. Lesions must be of at least 3 months duration and must not have been treated with topical steroids or retinoids for at least 3 weeks. Patient must have at least two similar lesions that can accommodate a 2X3 inch dressing. Patient must be willing to have two 4 mm biopsies prior to onset of therapy and four 4 mm biopsies at the end of the study period. In the absence of systemic involvement, the CDLE lesions must not have responded to at least 3 months of therapy with topical steroids, sunscreens with or without antimalarials such as hydroxychloroquine. If CDLE is present in association with systemic involvement, the lesions must not have responded to 3 months of stable conventional systemic therapy and/or topical steroids and sunscreens. If female, the patient must have a negative pregnancy test prior to study entry. If female, must be postmenopausal surgically sterile, sexually inactive, or practicing successful contraception with two methods of birth control simultaneously for at least one month prior to starting on thalidomide and continue use for another month after the last application of thalidomide. If male, the patient must be surgically sterilized, sexually inactive, or use a condom during the study and continue regular use until one month after the last application of thalidomide. Patients must have normal cognitive abilities to be able to understand the experimental nature of the therapy, to be able to follow instructions regarding application of medication and correct use of contraceptive measures. Patients must not be pregnant or lactating. Patients must not have renal disease (serum creatinine greater than 2 times the upper limit of normal. Patients must not have hepatic dysfunction (liver function tests greater than 2 times the upper limit of normal). Patients must not have unstable systemic lupus erythematosus such that systemic therapy cannot be maintained at steady doses for the duration of the study. Patients must not use topical steriods for the duration of the study. Patients must not be currently receiving systemic thalidomide. Patients must not be hypersensitive to thalidomide. Patients must not have presence of polyneuropathy (objective sensory loss or motor weakness or reflex loss) with the exception of focal nerve entrapment syndromes (such as carpal tunnel syndrome), or receiving drugs with known or suspected neuropathic side effects. Patients must not have any other condition or therapy which in the opinion of the investigators may pose a risk to the patient or confound the results of the study.
Total Enrollment: 17
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 980008; 98-C-0008
Study Start Date: October 2, 1997
Record last reviewed: September 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001680
Other Discoid Lupus Erythematosus Studies:
1. A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus
Related Studies:
Other Discoid Lupus Erythematosus Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus
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