A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Discoid Lupus Erythematosus
Intervention: Thalidomide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Cancer Institute (NCI)
Summary
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.
Clinical Details
Official title: A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus
Study design: Treatment, Safety/Efficacy Study
Detailed description:
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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 steroids 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.
Locations and Contacts
National Cancer Institute (NCI), Bethesda, Maryland 20892, United States
Additional Information
Related publications: Knop J, Bonsmann G, Happle R, Ludolph A, Matz DR, Mifsud EJ, Macher E. Thalidomide in the treatment of sixty cases of chronic discoid lupus erythematosus. Br J Dermatol. 1983 Apr;108(4):461-6. Schuler U, Ehninger G. Thalidomide: rationale for renewed use in immunological disorders. Drug Saf. 1995 Jun;12(6):364-9. Review. Gardner-Medwin JM, Smith NJ, Powell RJ. Clinical experience with thalidomide in the management of severe oral and genital ulceration in conditions such as Behcet's disease: use of neurophysiological studies to detect thalidomide neuropathy. Ann Rheum Dis. 1994 Dec;53(12):828-32.
Starting date: October 1997
Ending date: July 2001
Last updated: July 12, 2006
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