Track topics on Twitter Track topics that are important to you
Welichem Biotech has developed a small molecule drug candidate, WBI-1001, that selectively targets the pathogenic features of inflammatory skin diseases, including atopic dermatitis (a form of eczema).The purpose of this clinical trial is to further test the safety and efficacy of WBI-1001 as a topically applied cream over an extended period of 12 weeks on patients with mild to moderate atopic dermatitis.
A multi-centered, double-blinded Phase IIb study to evaluate the safety and efficacy of the non-steroid, anti-inflammatory WBI-1001 cream in the topical treatment of patients with mild to moderate atopic dermatitis, expressed as lesions up to 20% BSA. For the first 6 weeks patients will be randomized to one of three treatment groups simultaneously in a ratio of 1:1:1.
Group 1: vehicle cream (placebo), BID; Group 2: 0.5% WBI-1001 cream, BID; Group 3:1.0% WBI-1001 cream, BID. Patients randomized to treat all lesion areas.
After the first 6 weeks all patients will be treated, non-placebo controlled, with WBI-1001 cream. The Group 1 patients will enter a double-blinded phase for a further 6 weeks with half of them being treated BID with 0.5% and half with 1.0% WBI-1001 cream. Groups 2 and 3 will continue with their treatments unchanged for the remaining 6 weeks.
During the treatment period, patients will apply the cream (BID) from the kit that they have been provided, and they will visit the study centre at prescribed times for assessment of efficacy, safety and tolerability. After completion of the 12-week treatment period patients will have a 2-week follow-up visit.
Patients who withdraw from the study before Day 42 for reasons other than a treatment related AE will be replaced so that at least 40 patients per group will complete the placebo-controlled phase.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Guilford Dermatology Associates
Welichem Biotech Inc.
Published on BioPortfolio: 2014-08-27T03:14:46-0400
WBI-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug for the topical, cream treatment of inflammatory skin diseases. As such, it affects T-cells thr...
The purpose of this research study is to better understand how this study drug works when people use it to treat atopic dermatitis. Desonate has been approved by the US Food and Drug Admi...
Atopic Dermatitis is a chronic relapsing eczematous skin disease with increasing prevalence. Complementary and alternative medical approaches have been employed to relieve symptoms of Atop...
Atopic Dermatitis, also known as atopic eczema, or eczema, is a common skin disease that can affect males and females of all ages, but often starts in childhood. Recent studies show at lea...
The overall aim of this study is to assess the effects of a new treatment called Secukinumab in adults suffering from moderate to severe atopic dermatitis. Furthermore, the study shall sup...
For a considerable proportion of pediatric patients, atopic dermatitis symptoms persist into adolescence. Previous studies have focused mainly on (parents of) children, whereas little is known about a...
Atopic dermatitis is a chronic inflammatory skin disease. Methotrexate is an off-label systemic agent for treating uncontrolled atopic dermatitis.
To evaluate the treatment revolution atopic dermatitis, the most common inflammatory skin disease, has been going through in recent years, thanks to breakthroughs in disease understanding, delineating...
Despite being widely reported by patients with atopic dermatitis (AD), pain symptoms, unlike itch, have not been widely assessed.
The skin barrier is a dynamic innate immune organ. This review summarizes the current understanding of how deficiencies associated with atopic dermatitis invite other atopic disorders of the allergic ...
A disseminated vesicular-pustular eruption caused by the herpes simplex virus (HERPESVIRUS HOMINIS), the VACCINIA VIRUS, or Varicella zoster (HERPESVIRUS 3, HUMAN). It is usually superimposed on a preexisting, inactive or active, atopic dermatitis (DERMATITIS, ATOPIC).
The widespread involvement of the skin by a scaly, erythematous dermatitis occurring either as a secondary or reactive process to an underlying cutaneous disorder (e.g., atopic dermatitis, psoriasis, etc.), or as a primary or idiopathic disease. It is often associated with the loss of hair and nails, hyperkeratosis of the palms and soles, and pruritus. (From Dorland, 27th ed)
Antigens from the house dust mites (DERMATOPHAGOIDES), mainly D. farinae and D. pteronyssinus. They are proteins, found in mite feces or mite extracts, that can cause ASTHMA and other allergic diseases such as perennial rhinitis (RHINITIS, ALLERGIC, PERENNIAL) and atopic dermatitis (DERMATITIS, ATOPIC). More than 11 groups of Dermatophagoides ALLERGENS have been defined. Group I allergens, such as Der f I and Der p I from the above two species, are among the strongest mite immunogens in humans.
A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.
Rare autosomal recessive disease with variable expressions. Clinical features of the disease include variable ICHTHYOSIFORM ERYTHRODERMA, CONGENITAL; bamboo hair (trichorrhexis invaginata); and ATOPIC DERMATITIS. The disease is caused by mutations in the SPINK5 gene.
Biotechnology - Biotech
"using living things to create products or to do tasks for humans" About Biotechnology - Biotech Biotechnology is the practice of using plants, animals and micro-organisms such as bacteria, as well as biological processes - such as the ripen...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...