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Washington, D.C. — Georgetown researchers have found that patients suffering from scleroderma--a disease affecting an estimated 400,000 Americans that causes thickening of the skin, stiff joints and hardening of the internal organs--may experience improved mobility by taking the hormone relaxin.
Georgetown University Medical Center was one of 13 academic medical centers to participate in the clinical trial financed by Northern California-based Connetics Corporation, which manufactures relaxin.
"This is the first study in diffuse scleroderma that has shown significant improvement in skin thickening in a controlled trial," said Virginia Steen, M.D., Ph.D., one of the co-investigators who led the Georgetown study. "The drug appears to improve skin elasticity, giving patients more mobility."
The study, in which Dr. Steen enrolled eight of her patients, involved 68 patients with stable, moderate-to-severe diffuse scleroderma who had been diagnosed with the disease for five years or less. With more than 15 years of experience treating scleroderma, Dr. Steen has a database containing about 2,000 cases.
Patients involved in the trial were treated with a low dose or a high dose of relaxin, while others received a placebo. Some patients treated with the lower-dose relaxin experienced softening of the skin, and as a result, improved mobility in their hands, upper bodies, and mouths. Most patients treated with higher doses or a placebo did not experience these benefits.
If the results of a Phase II/III trial--expected later this year--are positive, the drug could be made available to patients with diffuse scleroderma as soon as next year.
Relaxin is a pregnancy-related hormone that decreases new connective tissue and promotes the breakdown of collagen. While preliminary tests indicate that the drug may reverse the skin hardening experienced by scleroderma patients, it is still unclear whether the drug prevents damage to the internal organs.
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