CLINICAL TRIAL REVIEW
March 2012 | Volume 11 | Issue 3 | Feature | 424 | Copyright © 2012
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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CUTANEOUS LUPUS ERYTHEMATOSUS
A Randomized, Subject and Investigator-Blinded (Sponsor-Open), Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Multiple Ascending Doses of PD- 0360324 in Subjects with Active Cutaneous Lupus Erythematosus (CLE)
This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in disease activity will also be evaluated. The primary outcome measure is to assess the safety and tolerability of PD-0360324 by physical examinations, adverse event and infection monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements.
Inclusion Criteria: Male and/or female subjects between the ages of 21 to 70 who have a clinical diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus with or without systemic lupus erythematosus prior to screening that has been confirmed by evaluation of skin biopsy sample; active disease at both screening and baseline (Day 1) defined by a CLASI score of greater than or equal to 10; intolerance to antimalarial therapy or more than 3 months of antimalarial therapy with disease activity.
Exclusion Criteria: Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months of Day 1; signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections; subjects with evidence of past or active tuberculosis; pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.
Topical Timolol 0.5% Solution for Proliferating In- fantile Hemangiomas: A Prospective Double Blind- ed Placebo Controlled Study
Sponsored by Oregon Health and Science University, the pur- pose of this study is to learn about a new potential use for topi- cal timolol 0.5% aqueous solution that may help treat small, un- complicated infantile hemangiomas. This study would examine whether topical timolol could be a potential therapy.
The primary outcome measure is to compare the proportion of subjects in treatment group and the placebo group, with at least a 75% improvement in the extent of the hemangioma as compared to baseline photos.
Inclusion Criteria: Infants 1 month to 8 months of age with infantile hemangioma (IH) who are 3 cm or less on the scalp, trunk, or extremities.
Exclusion Criteria: Subjects with facial, genital, perianal, hand, finger, feet, or toe IH; subjects with PHACES syndrome (proven) or suspected PHACES (plaque-like hemangioma on the face awaiting imaging); subjects with IH measuring more than 3cm in size or ulcerated; children with a history of hypersensitivity to beta blockers; children with a personal history of asthma; children with known renal impairment; children with known cardiac conditions that may predispose to heart block; personal history of hypoglycemia; children on medications that may interact with beta blockers.
MODERATE TO SEVERE PLAQUE- TYPE PSORIASIS
A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis
Sponsored by Novartis Pharmaceuticals, this study will assess the safety and efficacy of secukinumab compared to placebo in patients that have moderate to severe, chronic, plaque-type psoriasis. The