Last updated: 03/11/2019 20:40:09
BAP02147: POST-MARKETING OBSERVATIONAL STUDY OF THE ACTUAL USE, EFFECTIVENESS AND SAFETY OF TOCTINO® (ALITRETINOIN) IN THE TREATMENT OF CHRONIC HAND ECZEMA
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: BAP02147: POST-MARKETING OBSERVATIONAL STUDY OF THE ACTUAL USE, EFFECTIVENESS AND SAFETY OF TOCTINO® (ALITRETINOIN) IN THE TREATMENT OF CHRONIC HAND ECZEMA
Trial description: Toctino® (alitretinoin) has been granted a positive opinion for reimbursement in France on April 29th, 2009 by the French “Commission of Transparence”. This commission requested to undertake a long-term follow-up study of patients with severe chronic hand eczema treated with TOCTINO.The objectives of this study are to document, under real treatment conditions: characteristics of the patients treated; conditions of use; conditions for monitoring the treatment, particularly with regard to effective contraception in women of childbearing age; the impact of the treatment on morbidity, quality of life and social and/or professional impact of these lesions; frequency of treatment discontinuations and reasons for this; impact of adverse effects on the maintenance of treatment.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Alitretinoin long term efficacy evaluation
Timeframe: 12 and 18 months after the end of the treatment
Secondary outcomes:
Evaluation of the mTLSS and the relapse rate
Timeframe: M9, M12, M18, M24
responders rate
Timeframe: end of treatment
Profile of patients treated
Timeframe: M0
safety
Timeframe: anytime during the study
- Socio-economic and medico-economic consequences
Timeframe: anytime during the study
condition of use
Timeframe: anytime during treatment
time to response
Timeframe: end of treatment
Interventions:
Enrollment:
400
Primary completion date:
2015-18-12
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Halioua B., Paul C., Berbis P., Cambazard F., Doutre M.S., Joly P., Richard M.A., Aubin C., Gruber A., Chosidow O.. Efficacy and safety of oral alitretinoin as treatment of chronic hand eczema in France: a real-life open-label study. Eur J Dermatol. 2019;29(1):59-66
DOI: 10.1684/ejd.2018.3484
PMID: 30827949
Medical condition
Eczema
Product
alitretinoin
Collaborators
Not applicable
Study date(s)
December 2010 to December 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Male or female patients, older than 18, with CHE for whom the dermatologist has decided to prescribe Toctino® in accordance with the marketing authorization of the product.
- none (observational study)
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female patients, older than 18, with CHE for whom the dermatologist has decided to prescribe Toctino® in accordance with the marketing authorization of the product.
Exclusion criteria:
- none (observational study)
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
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
2015-18-12
Actual study completion date
2015-18-12
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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