subjects with moderate or severe atopic dermatitis. MedDRA version: 12.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis
Conditions
Interventions
Product Name: GW870086X
Product Code: GW870086X
Pharmaceutical Form: Cream
CAS Number: 827319-43-7
Current Sponsor code: GW870086X
Other descriptive name: Cyanomethyl
Concentration unit: % (W/W) perce
Sponsors
GlaxoSmithKline
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with a diagnosis of atopic dermatitis who are otherwise healthy. Diagnosis of atopic dermatitis: • Subject must have a documented history of atopic dermatitis as defined by Hanifin and Rajka and modified by Williams et al [Williams, 1994]. • Subject must present with moderate to severe atopic dermatitis as defined by a score of >25 using the modified SCORAD rating scale. • Subject must have at least 3 index lesions (=> 1cm2 in size) with a sum score of =>4 and 40 MlU/ml and estradiol 5% as assessed by the rule of nines method. 7. Patients must be willing to refrain from current active therapy for at least 10 days prior to dosing, 8. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 9. Single QTc, QTcB 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin =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 (21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of GW870086X cream (0.2% and 2%) applied once daily for 21 days on diseased skin of adult subjects with atopic dermatitis using the Three Item Severity (TIS) scale on Day 22.;Secondary Objective: • To investigate the efficacy of GW870086X cream (0.2% and 2%) applied once daily for 21 days on diseased skin of adult subjects with atopic dermatitis using the Three Item Severity (TIS) scale on Days 2, 3, 7 and 14. • To investigate the efficacy of GW870086X cream (0.2% and 2%) applied once daily for 21 days on diseased skin of adult subjects with atopic dermatitis using the Investigators Global Assessment scale (IGA) for atopic dermatitis. • To investigate the safety and tolerability of GW870086X cream (0.2% and 2%) applied once daily for 21 days on diseased skin of adult subjects with atopic dermatitis. • To assess the pharmacokinetic parameters of GW870086X cream (0.2% and 2%) applied once daily for 21 days. • To assess skin biopsy pharmacodynamic markers of GW870086X cream (0.2% and 2%) applied once daily for 21 days. ;Primary end point(s): • Change from baseline TIS scores between GW870086X (0.2% and 2%) versus placebo at Day 22. | — |
Countries
Germany
Outcome results
None listed