Study identification

PURI

https://redirect.ema.europa.eu/resource/4654

EU PAS number

EUPAS2474

Study ID

4654

Official title and acronym

Isotretinoin and the effectiveness of the pregnancy prevention programmes in Europe

DARWIN EU® study

No

Study countries

Italy
Norway
United Kingdom

Study description

Isotretinoin is effective in treating severe nodular acne vulgaris that is unresponsive to other therapies. It is, however, highly teratogenic when used during the first trimester of pregnancy and as a result, pregnancy prevention programs (PPPs) are in place committing female isotretinoin users to use ≥2 means of contraception. Research indicates that often, female isotretinoin users are unaware of these measures or do not adhere to them and the question arises as to why this should be the case. To ensure efficacy of PPPs, we need to determine what makes PPPs fail and what can be done to improve adherence. This study aims to use a combination of quantitative and qualitative research to provide an overview of isotretinoin use in women of childbearing age, to evaluate the effectiveness of the PPP and to develop and provide recommendations for improving the effectiveness of PPPs in Europe. The first 2 components of the study will use data from electronic healthcare databases in three European countries to determine the prevalence of oral isotretinoin use in females of childbearing age, to characterise its use in terms of demographic and clinical characteristics and to estimate factors predictive of PPP failure and the occurrence of pregnancies in women of childbearing age using isotretinoin. The qualitative component of the study will involve conducting interviews with women who have experienced a ‘breakthrough pregnancy’ whilst taking isotretinoin. In addition to the interviews a consultation exercise with a committee constituting representatives from across Europe of stakeholders from dermatology, hospital and community pharmacy, general practice, fertility specialists, teratology information services as well as female user representatives of childbearing potential will be carried out. All the information collected by the different components of this study will then be used to create a PPP failure model.

Study status

Finalised
Research institutions and networks

Institutions

Swansea University Medical School
United Kingdom
First published:
01/02/2024
InstitutionEducational InstitutionHospital/Clinic/Other health care facility
Emilia Romagna, SAIL, Tuscany database, Norwegian National Birth Cohort

Networks

EUROmediCAT

Contact details

Corinne de Vries

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

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

IsotretinoinFP7_University_of_Bath

English (514.27 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes