Last updated: 11/04/2018 12:52:26
Topical GW842470X In Adults Patients With Moderate Atopic Dermatitis
GSK study ID
TPD103280
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Randomised, double-blind, placebo-controlled study of topical GW842470X formulation in adults with moderate atopic dermatitis
Trial description: The purpose of this study is to investigate the clinical efficacy of 3% (w/w) GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI) assessment of disease severity and to investigate the safety of and tolerability of 3% GW842470X cream on diseased skin of adult patients.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW842470X cream
Enrollment:
190
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Atopic Dermatitis, Dermatitis, Atopic
Product
GW842470
Collaborators
Not applicable
Study date(s)
March 2006 to September 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- Moderate atopic dermatitis patients (IGA=3).
- The disease involvement must be >5% of body surface area.
- Patients with any active skin disease other than atopic dermatitis will not be eligible.
- Patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar, any corticosteroid, topical immunomodulators or oral treatment with any corticosteroids within 10 days prior to first application and/or oral anti-histamines within 5 days of the first dose.
Inclusion and exclusion criteria
Inclusion criteria:
- Moderate atopic dermatitis patients (IGA=3).
- The disease involvement must be >5% of body surface area.
- Female patients of child-bearing potential must use an appropriate method of contraception.
Exclusion criteria:
- Patients with any active skin disease other than atopic dermatitis will not be eligible.
- Patients who have had systemic treatment for atopic dermatitis or other topical or transdermal treatments (such as nicotine, hormone replacement therapies) within 14 days prior to first application of study medication and/or topical treatment with tar, any corticosteroid, topical immunomodulators or oral treatment with any corticosteroids within 10 days prior to first application and/or oral anti-histamines within 5 days of the first dose.
Trial location(s)
Location
GSK Investigational Site
Duelmen, Niedersachsen, Germany, 48249
Status
Study Complete
Location
GSK Investigational Site
Schenefeld, Schleswig-Holstein, Germany, 22869
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51063
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-22-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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