Randomised, double-blind, placebo-controlled study of topical GW842470X formulation in adult patients with moderate atopic dermatitis
- Conditions
- Atopic Dermatitis
- Registration Number
- EUCTR2005-005430-12-GB
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 (<1 month) active or presence of current superficial skin infections of viral aetiology such as herpes simplex, or varicella.
5. The subject has been diagnosed as having contact dermatitis in area of target lesions, seborrheic dermatitis and/or occupational eczema at predilection sites of atopic dermatitis.
6. The subject has had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 14 days prior to first application of study medication. Use of other topical preparations such as those containing vitamins, supplements or herbal within 14 days prior to application.
7. The subject has had systemic treatment for atopic dermatitis (including PUVA or UVB) within 14 days of the first dose of study medication.
8. Foreseeable intensive UV exposure during the study (solar or artificial). Subjects must not be exposed to intense direct sunlight for long periods, and must not use skin tanning devices (e.g. sunbed) for the duration of the study.
9. The subject has used topical treatment with tar or any corticosteroid or oral treatment with any corticosteroids within 10 days of the first dose of study medication.
Additionally, subjects who have taken oral immunosuppressants (e.g. cyclosporine azathioprine) within 1 month of the first dose of study medication.
10. History of cutaneous photodisorder, such as photoallergic reaction or polymorphic light eruption.
11. History of allergy to components of test medications, including vaseline, emollient or specific soap and adhesives to be used in the study.12. History of clinically significant cardiovascular, neurological, renal, endocrine or haematological abnormalities.
13. Subjects with a history of diaphoresis/excessive sweating not restricted to palms or face.
14. Subjects with a smoking history of >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 scre
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method