Atopic Dermatitis
Conditions
Interventions
Product Name: GW842470X
Product Code: GW842470X
Pharmaceutical Form: Cream
Current Sponsor code: GW842470X
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration num
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men or women. Women will be eligible to enter the study if they are: -Not pregnant or nursing. -Of non-child-bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). -Of child-bearing potential and using an appropriate method of contraception with a documented failure rate of less than 1% per year for the duration of the study and for 1 month after the last administration of investigational product 2. Aged 18 to 65 years. 3. Body weight = 50 kg (110 lbs) and BMI within the range of 17.5-32 kg/m2 inclusive where BMI =(weight in kg)/(height in meters)*2 4. Subjects with a diagnosis of atopic dermatitis but who are otherwise healthy. Healthy is defined as individuals who are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations. 5. Subjects must have body surface area (BSA) disease involvement of >5% as assessed by the rule of nines method. 6. Patients must be willing to wash out from current active therapy for at least 10 days prior to Day 1. 7. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form 8. A signed and dated written informed consent is obtained from the subject. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject presents with any systemic disorder or active skin disease (other than atopic dermatitis) (e.g. psoriasis) that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening. 2. The subject has atopic dermatitis restricted to the face, the feet or the hands only. 3. The subject has a current complication of atopic dermatitis such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated. 4. History of recent (10 cigarettes per day in the last 3 months. 15. Subjects taking dietary and herbal supplements, high strength mineral supplements (specifically Selenium (>75ug per day) and Zinc (>15mg per day)) or antiinflammatory drugs (e.g. corticosteroids, immunosuppressive drugs, or antihistamines). The use of stable therapy for 6 months for subjects with well controlled chronic disease (eg. hypertension, depression, anxiety, acid reflux, etc) and the use of multi-vitamin supplements are permitted at the discretion of the Principal Investigator/physician designee in consultation with the Medical Monitor where there is a question. 16. As a result of the medical interview, physical examination or screening investigations, the physician responsible (Principal Investigator or delegated physician) considers the subject unfit for the study. 17. The subject has plasma concentrations of aspartate-, alanine aminotransferase, total bilirubin, or alkaline phosphatases higher than the upper li
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI);Secondary Objective: To investigate the safety and tolerability of 3% GW842470X cream on diseased skin of adult patients with moderate atopic dermatitis To investigate the clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the SCORing Atopic Dermatitis score (SCORAD) and the Investigators Global Assessment scale (IGA) for Atopic Dermatitis To characterise the systemic exposure to GW842470X following 21 day dosing of 3% GW842470X cream on diseased skin of adult patients with atopic dermatitis To investigate histological biomarkers in a subgroup of adult patients with moderate atopic dermatitis Endpoint(s);Primary end point(s): Difference in change from baseline EASI scores between GW842470X Cohort vs. placebo (vehicle) Cohort | — |
Countries
Germany, United Kingdom
Outcome results
None listed