Non-steroid, Atopic Dermatitis Phase IIb 12-week Trial; Topical WBI-1001 Cream
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Dermatitis, Atopic
Intervention
WBI-1001
Location
Guilford Dermatology Associates
Surrey
British Columbia
Canada
V3R 6A7
Status
Recruiting
Source
Welichem Biotech Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01098734
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Kaposi Varicelliform Eruption
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).
Dermatitis, Exfoliative
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, Dermatophagoides
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.
Netherton Syndrome
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.
Dermatitis, Atopic
A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin (IgE), with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus. It is manifested by lichenification, excoriation, and crusting, mainly on the flexural surfaces of the elbow and knee. In infants it is known as infantile eczema.
Clinical Trials
Phase IIa Study of WBI-1001 Cream for Atopic Dermatitis
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...
Efficacy of Desonide (Desonatetm) Gel 0.05% in Younger and Older Subjects With Atopic Dermatitis
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...
A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
The purpose of the study is to determine whether the topical application of BRT-FC-83C is effective in the treatment of mild to moderate atopic dermatitis.
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
Histamine Pharmacogenetics in Children With Atopic Dermatitis
The primary goal of the study is to investigate the impact of a common genetic polymorphism in a histamine detoxification enzyme that may well have a common role in regulating the expressi...
PubMed Articles
What is Intrinsic Atopic Dermatitis?
Many authors favor a distinction between the extrinsic and intrinsic forms of atopic dermatitis. In this review, the controversy is discussed and several definitions are presented. After reviewing man...
Th-2-biased immune responses are known to play a key role in the pathogenesis of atopic dermatitis. In particular, the macrophage-derived chemokine CCL22 is directly implicated in Th-2-associated skin...
Prevalence of atopic disorders in rheumatic diseases.
OBJECTIVES: The aim of this study was to assess the point prevalences of hay fever, asthma, and atopic dermatitis in OA, RA, and AS, and to compare with healthy controls. METHODS: A total of 935 patie...
Japanese patients with psoriasis and atopic dermatitis show distinct personality profiles.
Personality and emotional factors are supposed to influence the course of skin diseases, such as psoriasis and atopic dermatitis. Few reports exist, however, showing distinct personality traits among...
The Infectious Aspects of Atopic Dermatitis.
Atopic dermatitis is characterized by Staphylococcus aureus colonization and recurrent skin infections. In addition to an increased risk of invasive infections by herpes simplex or vaccinia viruses, t...
