Last updated: 02/06/2024 05:06:24
BAP02147: OBSERVATIONAL STUDY TO COMPARE CLINICAL SCORES AND EXPERT PHOTOGRAPH SCORES IN PATIENTS WITH SEVERE CHRONIC HAND ECZEMA BEFORE AND AFTER TREATMENT WITH ORAL ALITRETINOIN (TOCTINO®)
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: OBSERVATIONAL STUDY TO COMPARE CLINICAL SCORES AND EXPERT PHOTOGRAPH SCORES IN PATIENTS WITH SEVERE CHRONIC HAND ECZEMA BEFORE AND AFTER TREATMENT WITH ORAL ALITRETINOIN (TOCTINO®)
Trial description: The PIXALI study, although sponsored by GSK, was an academic initiative supported by top level experts in France (the GERDA group). PIXALI addresses a original medical question as it aims at demonstrating a concordance between clinical diagnostic performed by investigators and central photographs reading (scientific committee) which could lead to the development of a telemedicine application.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
to assess the correlation between the clinical evaluation by the dermatologist AND the evaluation performed by the SC on the photographs of the lesions before and after Toctino treatment
Timeframe: M0, M6
Secondary outcomes:
tolerability: reporting adverse effects
Timeframe: M0-M6
assessment of the evolution of the symptoms
Timeframe: M6
responder rates
Timeframe: M6
assessement of the evolution of pruritus and pain
Timeframe: M0, M6
Interventions:
Not applicable
Enrollment:
89
Primary completion date:
2015-28-10
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Eczema
Product
alitretinoin
Collaborators
Not applicable
Study date(s)
September 2011 to October 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Men or women 18 years of age and older suffering from SCHE that is not responding to strong topical corticosteroids, for which reason the dermatologist has deemed it useful and necessary to start treatment with oral alitretinoin in compliance with the MA conditions, including managing the risk of teratogenicity (implementation of PPP [pregnancy prevention program]) in women of childbearing age.
- In order not to modify the observation conditions, there are no exclusion criteria for patients, other than the fact that they do not meet the conditions and precautions for using alitretinoin (legal provisions) or do not agree to participate in this study. In order to respect the strictest confidentiality concerning the photos that are transmitted, all signs that could be used for the purposes of recognition, such as tattoos or piercings, for example, will be considered exclusion criteria.
Inclusion and exclusion criteria
Inclusion criteria:
- Men or women 18 years of age and older suffering from SCHE that is not responding to strong topical corticosteroids, for which reason the dermatologist has deemed it useful and necessary to start treatment with oral alitretinoin in compliance with the MA conditions, including managing the risk of teratogenicity (implementation of PPP [pregnancy prevention program]) in women of childbearing age.
Exclusion criteria:
- In order not to modify the observation conditions, there are no exclusion criteria for patients, other than the fact that they do not meet the conditions and precautions for using alitretinoin (legal provisions) or do not agree to participate in this study. In order to respect the strictest confidentiality concerning the photos that are transmitted, all signs that could be used for the purposes of recognition, such as tattoos or piercings, for example, will be considered exclusion criteria.
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
2015-28-10
Actual study completion date
2015-28-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website