A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus

March 3, 2008 updated by: National Cancer Institute (NCI)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Study Completion

July 1, 2001

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

September 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 980008
  • 98-C-0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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