Last updated: 11/07/2018 11:27:36
A focus on patients with CHE: Recording of influential factors on the quality of life, work productivity and progression of treatment while taking Toctino®PASSION
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A focus on patients with CHE: Recording of influential factors on the quality of life, work productivity and progression of treatment while taking Toctino®
Trial description: The aim of this non-interventional study is to obtain detailed information on specific parameters from patients suffering from severe chronic hand eczema (CHE) that is refractory to the treatment with potent topical corticosteroids and who are being treated with Toctino® according to the indication and guidelines, which may have an effect on the course of the treatment and success with Toctino® and thus may have a correlating effect on the quality of life and work productivity of the patient.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
quality of life measure
Timeframe: 24 weeks
Secondary outcomes:
PGA
Timeframe: screening
Interventions:
Not applicable
Enrollment:
608
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Thaci D, Augustin M, Westermayer B, Kamps A, Hennig M. Effectiveness of alitretinoin in severe chronic hand eczema: PASSION, a real-world observational study. J Dermatolog Treat. 2016;27(6):577-583.
Medical condition
Eczema
Product
alitretinoin
Collaborators
Not applicable
Study date(s)
November 2011 to November 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- patients suffering from severe chronic hand eczema (CHE) that is refractory to the treatment with potent topical corticosteroids and who are being treated with Toctino®
Inclusion and exclusion criteria
Inclusion criteria:
- patients suffering from severe chronic hand eczema (CHE) that is refractory to the treatment with potent topical corticosteroids and who are being treated with Toctino®
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
Protocol
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
2013-07-11
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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