CLINICAL TRIAL REVIEW
March 2012 | Volume 11 | Issue 3 | Features | 424 | Copyright © March 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.
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-
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