Clinical Trial Review

May 2013 | Volume 12 | Issue 5 | Feature | 596 | Copyright © 2013

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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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ERYTHEMA

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. Adult subjects with moderate to severe facial erythema of rosacea will be randomized at baseline/visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject’s randomization scheme). Subjects will requalify based on inclusion/exclusion before period 2 treatment.

The primary outcome measure is composite success from baseline to day 15, defined as an improvement on both the clinician’s and the subject’s erythema assessments at the end of each treatment period. The secondary outcome measure is onset of action, defined as an improvement on both the clinician’s and subject’s erythema assessments at 30 minutes postbaseline application.

Male and female adult subjects aged 18 years and older with a clinical diagnosis of facial rosacea are eligible for this study. Prior to enrollment, subjects must have a clinician’s assessment score of moderate to severe erythema, a self-assessment score of moderate to severe redness, and no to mild facial inflammatory lesions of rosacea.

Female patients who are pregnant, nursing, or planning a pregnancy during the study will be excluded. Additional exclusion criteria include: 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 with conditions causing facial erythema that would confound the assessment of treatment; subjects who are taking or have recently taken medications known to have interactions with α2-adrenergic agonists; and subjects with known allergies or sensitivities to one of the components of the investigational products.

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SKIN CANCER

Phase I/II Study of Metastatic Melanoma Using Lymphodepleting Conditioning Followed by Infusion of Tumor Infiltrating Lymphocytes Genetically Engineered to Express IL-12

Sponsored by the National Cancer Institute (NCI), this study aims to determine the safety and effectiveness of cell therapy using IL-12 modified tumor white blood cells to treat metastatic melanoma.

The primary outcome measure is to evaluate the safety of the administration of IL-12 engineered TIL in patients receiving a non-myeloablative conditioning regimen, and to determine if its administration will result in clinical tumor regression in patients with metastatic cancer.

Individuals with metastatic melanoma, 18 years or older, who are willing to sign a durable power of attorney, and are able to understand and sign the Informed Consent Document are eligible. Participants must have clinical performance status of ECOG 0 or 1 and a life expectancy of greater than 3 months. Patients of both genders must be willing to practice birth control from the time of enrollment on this study and for up to four months after receiving the preparative regimen. Participants must also be seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune-competence and thus less responsive to the experimental treatment and more susceptible to its toxicities.). Patients must also be seronegative for hepatitis B antigen and for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative. Women of childbearing potential must have a negative pregnancy test because of the potentially dangerous effects of the preparative chemotherapy on the fetus. Participants must have an absolute neutrophil count greater than 1000 per mm3 without the support of filgrastim; a WBC greater than 3000 per mm3; a platelet count greater than 100,000 per mm3; and hemoglobin greater than 8.0

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