PSOLEMEE - Localized psoriasis: a pharmaco-economic evaluation 
Head :
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Last update : 09/05/2017 | Version : 2 | ID : 2849
| General | |
| Identification | |
| Detailed name | Localized psoriasis: a pharmaco-economic evaluation |
| Sign or acronym | PSOLEMEE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 08.493bis, CNIL 908462 |
| General Aspects | |
| Medical area |
Dermatology, venereology |
| Health determinants |
Medicine |
| Keywords | cost, pharmaco-economic study, Psoriasis, quality of life, cohort, pharmacoepidemiology, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Laboratoire GENEVRIER |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Two independent observational cohorts of patients with chronic plaque psoriasis were formed. The first, "physician cohort", was composed of patients from a random sample of general practitioners and dermatologists (hospital and non-hospital). The second, "association cohort", was composed of patients selected through the website of a psoriasis patient association. |
| Database objective | |
| Main objective | The main objective of this study was to evaluate the cost of psoriasis care for patients corresponding to the target population of BETESIL®, i.e. those suffering from chronic plaque psoriasis, localized in areas difficult to treat (knees, elbows, and anterior surface of the tibia, not exceeding 5% of body surface area). |
| Inclusion criteria | Patient aged 18 years or above; Patient with chronic plaque psoriasis; Patient with plaques located in places difficult to treat (knees, elbows, and anterior tibia, not exceeding 5% of the body surface area); Patient able to understand or complete the study questionnaires; patient who can be followed for 6 months; patient agreeing to participate in the study. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Dermatologists and general practitioners in France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 475 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire Phone interview |
| Administrative data (detail) | Name, first name, home address, email address, phone number |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | The inclusion data were collected by physicians or dermatologists (medical questionnaire), by patients (self-administered questionnaire) and CRA (telephone questionnaire). During the follow-up at 3 and 6 months, data were collected by patients (self-administered questionnaire) and CRA (telephone questionnaire). |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Patients were contacted by post at 3 and 6 months to complete a standard self-administered questionnaire (general data regarding psoriasis, quality of life) and by a CRA to complete a standard telephone questionnaire (drugs and cosmetics, consultations, examinations, surgery, hospitalization, sick leave, phototherapy, spa therapy). |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | A study report was delivered to the pharmaceutical company after validation by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University Bordeaux Segalen and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
