Last updated: 11/07/2018 11:41:57
Longitudinal Analysis of Efficacy and Safety of Alitretinoin in Patients with Severe Chronic Hand Eczema Refractory to Corticosteroidsdose-response
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Longitudinal Analysis of Efficacy and Safety of Alitretinoin in Patients with Severe Chronic Hand Eczema Refractory to Corticosteroids
Trial description: The exposure-response of alitretinoin (an inlicensed product licensed in Europe, but investigational in US) was conducted to characterize the optimal dose and duration of treatment and to address what covariates (e.g., dose, age, weight) that may affect efficacy and/or safety
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Physicians Global Assessment
Timeframe: 1,4,8,12,16,20,24,48
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1442
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Other
Clinical publications:
GD Schmith, R Singh, R Gomeni, O Graff, AG Hamedani, JS Troughton and SM Learned.Longitudinal Analysis of Efficacy and Safety of Alitretinoin in Patients with Severe Chronic Hand Eczema Refractory to Corticosteroids. CPT Pharmacometrics Syst Pharmacol.2015;4(4):255-262
Medical condition
Eczema
Product
alitretinoin
Collaborators
GSK
Study date(s)
January 2013 to April 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18 - 85 Year
Accepts healthy volunteers
none
- N/A
- N/A
Inclusion and exclusion criteria
Inclusion criteria:
- N/A
Exclusion criteria:
- N/A
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2013-15-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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