Study identification

PURI

https://redirect.ema.europa.eu/resource/49667

EU PAS number

EUPAS31095

Study ID

49667

Official title and acronym

Impact of EU label changes and revised pregnancy prevention programme for oral retinoid containing medicinal products: utilization and prescribing trends

DARWIN EU® study

No

Study countries

Denmark
France
Italy
Netherlands
Spain

Study description

Oral retinoids are used to treat dermatological conditions like severe acne vulgaris (isotretinoin) psoriasis (acitretin) and chronic hand eczema (alitretinoin), some oral retinoids are also used to treat skin manifestations of T-cell lymphoma (bexarotene) and acute promyelocytic leukaemia (tretinoin). All oral retinoids are highly teratogenic and must not be used during pregnancy. The aim of this study is to investigate the use of oral retinoid containing medicinal products authorised in the EU before and after implementation of the 2018 revised measures for pregnancy prevention in clinical practice.

Study status

Finalised
Research institutions and networks

Institutions

Danish National Registries Denmark, BIFAP Spain, FISABIO Valencia, Spain, Caserta Camania, Italy, Palermo Sicily, Italy, SNIRAM France

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

Protocol Retinoids V0.5 19SEP2019

English (1.71 MB - PDF)View document
Updated protocol

AMEND Protocol Retinoids V1.2 17DEC2021

English (1.34 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable