CLINICAL TRIAL REVIEW
May 2012 | Volume 11 | Issue 5 | Features | 671 | Copyright © May 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.
SEVERE ATOPIC DERMATITIS
A Pilot Study Using Anakinra/Kineret for the Treatment
of Patients With Severe Atopic Dermatitis
Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), this study aims to assess the safety and effectiveness
of using anakinra to treat severe atopic dermatitis (AD) in children. The primary outcome measure is the improvement of AD symptoms without increase in serious infections, along with a response to treatment with a 30% decrease in SCORAD score within 2 years.
Male or female participants from 10 years to 18 years of age, with a SCORAD score greater than 40, whose AD has been unresponsive
to topical corticosteroids for greater than 6 months, with a skin test or radioallergosorbent test (RAST) showing sensitivity to greater than or equal to 3 food and/or airborne allergens are eligible.
Participants must have a baseline CBC that demonstrates a white blood cell count, an absolute neutrophil count, and a platelet
count greater than or equal to lower limit of normal for age, and must not be pregnant or breastfeeding. If subject is a female who has begun menstruation, she must agree to consistently use contraception throughout study participation. Participants also must have a primary care physician and must be willing to submit blood and skin tissue for storage.
Participants cannot use oral or injectable immunomodulators, biologics, or require systemic immunosuppression at any time during the study. Patient cannot have known diseases of immunodysregulation
or immunodeficiency, nor any chronic medical condition other than atopic dermatitis, history of anaphylactic reaction, or hypersensitivity to anakinra. Further, the patient cannot have the presence of certain types of acquired abnormalities
of immunity such as human immunodeficiency virus (HIV), nor have a diagnosis of active tuberculosis with consistent
findings from a PPD skin test, computerized tomography (CT) scan, or Chest x-ray. The patient cannot have received a live vaccine within 4 weeks prior to therapy or potential need for a live vaccine during the study. Finally, the patient must be willing and able to undergo all testing or procedures associated with this protocol, including daily injections.
CHRONIC PLAQUE PSORIASIS
Safety and Efficacy of Secukinumab Compared to Etanercept 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 and etanercept in patients with moderate to severe, chronic, plaque-type psoriasis. The primary outcome measure is to evaluate the efficacy of secukinumab compared to placebo in subjects with moderate to severe chronic plaque-type psoriasis,
Participants with chronic, plaque-type psoriasis for at least 6 months, based on PASI greater than 12, IGA greater than 3, and greater than 10% body surface area that has been inadequately controlled by prior treatments.
Participants cannot have forms of psoriasis other than chronic, plaque-type (eg, pustular, erythrodermic, and guttate psoriasis)
or drug-induced psoriasis, nor can participants use other psoriasis treatments during the study. Participants cannot have used etanercept or secukinumab during the study. Pregnant or lactating women, or women who do not agree to use contraception
during the study and for 16 weeks after stopping treatment will be excluded. Participants with significant medical
problems, eg, uncontrolled high blood pressure, congestive heart failure, history of an ongoing, chronic, or recurrent infection
or evidence of tuberculosis, or allergy to rubber or latex are excluded
BASAL CELL CARCINOMA AND SQUAMOUS CELL CARCINOMA
Electronic Brachytherapy for the Treatment of NMSC
Sponsored by Xoft, Inc., this study will record recurrence in patients treated for nonmelanoma (basal cell and squamous cell carcinomas) skin cancer using the Xoft Axxent Electronic Brachytherapy System. The primary outcome measure is to evaluate the local recurrence of NMSC.