CLINICAL TRIAL REVIEW

September 2012 | Volume 11 | Issue 9 | Original Article | 1136 | 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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ACNE VULGARIS

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Gevokizumab in Subjects With Moderate to Severe Acne Vulgaris

Sponsored by XOMA (US), LLC, the purpose of this study is to determine whether gevokizumab is effective in the treatment of moderate to severe acne vulgaris.

The primary outcome measure is the mean absolute change from baseline in inflammatory facial lesion count at Day 84.

Inclusion criteria include a diagnosis of moderate to severe acne vulgaris that is unresponsive to oral antibiotics and a willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study.

Exclusion criteria include a use of medications or treatments from specified pre-treatment time periods through the end of the study. Participants cannot have a beard, moustache, sideburns, or other facial hair that may interfere with evaluation or other forms of acne. Participants cannot have a history of malignancy within 5 years, allergic or anaphylactic reactions to monoclonal antibodies, or have tuberculosis or chronic systemic infections. Female subjects who are pregnant, or planning to become pregnant are also prohibited.

table 1

ROSACEA

A Multicenter, Randomized, Controlled, Double-Masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea

Sponsored by Galderma Laboratories, L.P., the purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once-daily vs azelaic acid gel 15% applied topically twice-daily in subjects with moderate to severe facial erythema of rosacea.

The primary outcome measure is the composite success, defined as an improvement on both the clinician's and subject's erythema assessments at the end of each treatment period.

Males and females aged 18 years or older, with a clinical diagnosis of facial rosacea, and a clinician's assessment score of moderate to severe erythema prior to enrollment are eligible for the study. Participants must have a self assessment score of moderate to severe redness prior to enrollment, with none to mild facial inflammatory lesions of rosacea prior to enrollment.

Female subjects who are pregnant, nursing or planning a pregnancy during the study are ineligible, as are subjects with a condition or who are in a situation, which in the Investigator's opinion may put a subject at risk, may confound study results, or may interfere with a subject's participation in the study. Subjects cannot have conditions causing facial erythema that would confound the assessment of treatment, nor can the participants be taking or have recently taken medications known to have interactions with α-2 adrenergic agonists. Subjects cannot have known allergies or sensitivities to one of the components of the investigational products.

table 2

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)

Sponsored by Pfizer, 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 the safety and tolerability of PD-0360324, which will be assessed by physical examinations, adverse event and infection monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements.

Male and female subjects from the ages of 21 to 70, with 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

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