Clinical Trial Review

July 2012 | Volume 11 | Issue 7 | Feature | 888 | 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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ROSACEA

A Single Site Evaluation of the Effect of Topical Application of Aminocaproic Acid (ACA) to Inhibit Kallikrein 5 Serine Protease Activity and Production of LL-37 Cathelicidin Peptide, Biochemical Markers of Rosacea-specific Inflammation
Sponsored by University of California, San Diego, the purpose of this study is to determine the effect of topical aminocaproic acid on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's immune system in patients with rosacea by inhibiting activation of antimicrobial peptides. The primary outcome measure is a determination of the effect of aminocaproic acid on the antimicrobial peptide cathelicidin in adult skin from patients with rosacea.

Male and non-pregnant females, 18-70 years of age with mild/ moderate papulopustular rosacea (3-20 papulopustules) and at least mild erythema are eligible. Participants must have been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study. Subjects must be in general good health with a calculated creatinine clearance 100% of normal range. Subjects must have normal baseline labs or in the opinion of the investigator are values are not clinically significant and would not inhibit the ability to monitor the patient for both safety and efficacy throughout the study.

Subjects cannot have a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans) or a history of Carcinoid, Pheochromocytoma, Serotonin Syndrome, or other systemic flushing causes. Subjects cannot have used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days, or systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days. Subjects cannot have laser or light-based treatment for rosacea within the prior 3 months, systemic retinoids and retinoid derivatives over the past 6 months or active or recent history of any coagulation (hyper or hypo) disorder, genitourinary bleeding, myopathy, cardiomyopathy, rhabdomyolysis, or evidence of clinically significant hepatic disease in the opinion of the investigator. Subjects cannot be taking any medicines or supplements that interfere with blood clotting such as Coumadin, Plavix, or ASA (>81mg/day), have a known hypersensitivity or allergy to aminocaproic acid or components of the vehicle, be pregnant or lactating or planning a pregnancy during the duration of the study. Subjects cannot have been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study, nor can subjects have clinically significant findings, medical history, or conditions (other than rosacea) that in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation.

table 1

ROSACEA

Comparison of the Efficacy Between Pulsed Dye Laser (PDL) and the Microsecond 1064-nm Nd:YAG Laser for Treatment of Diffuse Facial Redness: A Pilot, Prospective Randomized Trial
Sponsored by Northwestern University, the objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG laser in the treatment of facial redness. The primary objective of this study is to compare the efficacy of PDL and the 1064-nm Nd:YAG laser in the treatment of facial redness.

Healthy patients 18-55 years of age with erythematotelangiectatic rosacea (as verified by the PI) are eligible.

Subjects cannot be pregnant or lactating, unable to understand the protocol or to give informed consent, have a known history of photosensitive conditions (eg, systemic lupus, polymorphous light eruption), facial telangiectasia of diameter greater than 2 mm or significant (as determined by the PI) acute inflammatory papules, pustules, and vesicles involving the central face.

table 2

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