Clinical Trial Review

April 2012 | Volume 11 | Issue 4 | Feature | 548 | Copyright © 2012

Abstract

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

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ONYCHOMYCOSES

1320 nm Nd:YAG Laser for Improving the Appearance of Onychomycosis

Sponsored by the University of California, Irvine, the purpose of this clinical study is to improve the appearance of onychomycosis and morphology of the nail. The researcher can use a light based therapy to gently heat the toenail infected with fungus to improve the appearance of onychomycosis. The primary outcome measures are improving fungal nail infection within time frame of 6 months.

Inclusion Criteria: Adult Male/ female has been diagnosed with fungal nail infection on both great toenails.

Exclusion Criteria: Any other toenail disease including, but not limited to psoriasis, lichen planus, pachyonychia congenita, etc. as determined by the investigator; excessively thick or hypertrophic nails; subjects with diabetes; subjects that are pregnant; receipt of any topical therapy for onychomycosis (i.e. antifungal) within 2 weeks of enrollment, systemic therapy for onychomycosis (i.e. antifungal) within 3 months of enrollment, or any other procedures done on the test area within 6 months of enrollment; subjects with impaired immune systems including, but not limited to HIV, transplant patients on immunosuppression, etc.; current or history of psychiatric disease that would interfere with ability to comply with the study protocol or give informed consent; history of alcohol or drug abuse that would interfere with ability to comply with the study protocol.

table 1

PSORIASIS

A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE)

Sponsored by Janssen Inc., the purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the treatment of patients with moderate to severe plaque psoriasis. The primary outcome is an overall assessment of induration, scaling, and erythema and a PGA score of cleared or minimal within time frame of week 16.

Inclusion Criteria: Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent; must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment); must be considered, in the opinion of the investigator, suitable candidates for adalimumab therapy; if a woman, she must be postmenopausal, or if premenopausal, she must be either surgically sterile, practicing a highly effective method of birth control, or not heterosexually active during the study and for 5 months after receiving the last dose of study drug; if a man, he must agree to use a double-barrier method of birth control (or must have been surgically sterilized) and to not donate sperm during the study and for 5 months after receiving the last dose of study drug.

Exclusion Criteria: History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease; has a contra-indication to anti-TNF therapy; has a history of chronic or recurrent infectious disease; has a nonplaque form of psoriasis or has drug-induced psoriasis; has been previously treated with adalimumab; has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23, (including but not limited to ustekinumab, briakinumab [ABT-874], AIN457, and SCH900222) within 6 months of the first administration of study agent.

table 2

MELANOMA

A Phase II Study of Sunitinib Versus Dacarbazine in the Treatment of Patients With Metastatic Uveal Melanoma (SUAVE)

This study aims to find out how well Sunitinib works to treat uveal melanoma and to see how long Sunitinib and Dacarbazine can help to prevent the cancer from getting worse. The primary outcome measure for this trial is the progression-free survival time measured from date of randomisation. For patients with evidence of progressive disease (as measured by CT scan, or MRI if necessary) or patients who have died from any cause, progression-free

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