CLINICAL TRIAL REVIEW
February 2012 | Volume 11 | Issue 2 | Feature | 276 | 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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Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis
Sponsored by GlaxoSmithKline, this study investigates the safety and effectiveness of Altabax ointment (Retapamulin 1%) use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes. The primary outcome measure is bacteriological culture.
Inclusion criteria: Female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice a reliable method of contraception; secondary infection of atopic dermatitis with S. aureus or S. pyogenes as the probable causative agent; an infected area less than or equal to 100 cm2 for subjects aged 18 years or older, or 2% body surface area for subjects under 18 years of age; skin Infection Rating Scale score greater than or equal to 8; able to understand and comply with the requirements of the study and sign informed consent/HIPAA authorization forms; and subjects under the legal age of consent must also have the written informed consent of parent or legal guardian.
Exclusion criteria: Female subjects who are pregnant, trying to get pregnant, breast-feeding, or who are of childbearing potential and not practicing reliable birth control; allergic to any component of the test medication; clinical diagnosis of impetigo, folliculitis, or minor soft tissue infection; use of topical antibacterial medication to the study treatment area within one day of visit 1; signs of systemic infection or evidence of abscess or cellulitis at the site to be treated; medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the clinical study; recent alcohol or drug abuse is evident; history of poor cooperation, noncompliance with medical treatment or unreliability; and participation in an investigational drug study within 30 days of baseline visit.
ACUTE GRAFT VERSUS HOST DISEASE
The Use of Etanercept Enbrel as Sole Treatment for Grade I Acute Graft Versus Host Disease
Sponsored by the University of Michigan Comprehensive Cancer Center, this study aims to determine if treatment with etanercept for early skin graft-versus-host disease (GVHD) can effectively treat and prevent progression of the disease without using high dose steroids. The primary outcome measure is to determine with statistical certainty that treatment with etanercept alone for grade I (stage 1-2 skin only) acute graft versus host disease (GVHD) will reduce the percentage of patients who progress within 28 days of initiation of etanercept treatment, from 58% to 38%.
Inclusion criteria: Patient must have undergone HCT (donor cells from any source) with either a myeloablative or nonmyeloablative preparative regimen. Patient may be any age; patient must have biopsy-proven grade I acute GVHD. Biopsy report does not have to be back from pathology prior to enrollment. Patients whose biopsy for GVHD identifies pathology inconsistent with GVHD will be removed from the study and replaced. However, because GVHD is a clinical diagnosis, biopsies that are nondiagnostic or do not show a clear non-GVHD etiology will not be cause to remove the patient from the study.
A One-Year Study to Evaluate the Efficacy and Safety of CP-690,550 for Patients With Moderate to Severe Chronic Plaque Psoriasis
Sponsored by Pfizer, this trials aims to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.