Last updated: 02/20/2024 09:22:08

Participant and prescriber survey to assess awareness, knowledge and adherence to the Pregnancy Prevention Program (PPP) for oral retinoids

GSK study ID
209962
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Survey: Patient and Prescriber Survey: Effectiveness measures to investigate awareness, knowledge and adherence to the Risk Minimisation Measures (RMMs) of the Pregnancy Prevention Program (PPP) for Oral Retinoids (Acitretin, Alitretinoin, and Isotretinoin) DUS: Evaluation of the effectiveness of pregnancy prevention programme (PPP) for oral retinoids (acitretin, alitretinoin, and isotretinoin): a European before-after drug utilisation study (DUS) using secondary data
Trial description: This survey study (EU PAS Register Number: 38096) (PASS Category 3) is complementary to a drug utilization study (DUS) (PASS Category 1) (EU PAS Register Number: 32302). Both are being conducted as a requirement for EU marketing authorization to assess the effectiveness of updated risk minimization measures (RMMs) which have been incorporated as part of the Pregnancy Prevention Plan (PPP). The survey will be cross-sectional and multinational, conducted among healthcare professionals (HCPs) and participants in European countries to assess the effectiveness of the updated RMMs among female oral retinoid participants of childbearing potential and their prescribers participant's and prescriber's (HCP's) based on pre-defined success thresholds for PPP awareness, knowledge and adherence. Sample size of 450 completed HCP questionnaires and 150 completed questionnaires from participants who have been prescribed with oral retinoids according to the local label. Additionally, a sample boosting will happen after reaching the target size of the original sample of 450 HCPs and 150 participants. It will aim to include a total of 75 additional HCPs and 70 additional participants for alitretinoin.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Proportion of HCPs and participants aware of the PPP and RMMs for oral retinoids

Timeframe: Up to 6 months

Proportion of HCPs and participants knowledgeable about the important risks associated with oral retinoid use in women of childbearing potential

Timeframe: Up to 6 months

Proportion of HCPs and participants adherent to the RMMs of PPP

Timeframe: Up to 6 months

Secondary outcomes:

Proportion of HCPs and participants aware of updated PPP

Timeframe: Up to 6 months

Proportion of HCPs and participants knowledgeable about the risks and RMMs associated with use of oral retinoids

Timeframe: Up to 6 months

Proportion of HCPs and participants adherent to the RMMs of updated PPP

Timeframe: Up to 6 months

Interventions:
  • Other: Online Questionnaire
    • Enrollment:
    600
    Primary completion date:
    2021-01-10
    Observational study model:
    Cohort
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Eczema
    Product
    alitretinoin
    Collaborators
    ALFASIGMA ESPANA, ALLIANCE PHARMACEUTICALS LIMITED, ALMIRALL, ARITO PHARMA, AUROBINDO, BAILLEUL, BAUSCH HEALTH COMPANIES, DERMAPHARM, ENNOGEN, ESPECIALIDADES FARMACEUTICAS CENTRUM, S.A. EXPANSCIENCE, FIDIA, GALENPHARMA, GAP, GlaxoSmithKline, HADJICONSTANTINOU BROS, HEXAL AG, IASIS PHARMA, INDUSTRIAL FARMACEUTICA CANTABRIA, S.A., ISDIN, MEDINFAR, MYLAN, ORIFARM, PELPHARMA, PHARMATHEN, PIERRE FABRE, ROCHE, SMB, STADA, SUN PHARMA, TARGET, TEVA
    Study date(s)
    March 2021 to March 2022
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    13 - 49 Years
    Accepts healthy volunteers
    No
    • HCPs:
    • HCPs who prescribed or administered oral retinoids (acitretin, alitretinoin and isotretinoin) to female participants of childbearing potential in the past 6 months.
    • HCPs:
    • Inactive and retired HCPs (when documented information is available to identify them) will be deleted from the contact lists before randomization.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • HCPs:
    • HCPs who prescribed or administered oral retinoids (acitretin, alitretinoin and isotretinoin) to female participants of childbearing potential in the past 6 months. Participants:
    • Female participants of childbearing age (i.e., 13 to 49 years of age)
    • Receiving prescriptions for oral retinoids (acitretin, isotretinoin or alitretinoin) at the time of the survey, or who have received prescriptions within the last 6 months.
    • Willing, understanding and consenting to participate in this self-administered survey. For participants between 13 to 17 years of age, the survey shall be filled out by their parent, guardian or caregiver.
    Exclusion criteria:
    • HCPs:
    • Inactive and retired HCPs (when documented information is available to identify them) will be deleted from the contact lists before randomization.
    • HCPs who are not involved in participant treatment (e.g. researchers).
    • HCPs who may have conflicts of interest with the survey (i.e., HCPs employed by regulatory bodies, pharmaceutical companies).
    • HCPs who belong to a practice from which there are already at least two other HCPs participating in the survey.
    • HCPs who have participated in testing the questionnaire for comprehensibility, consistency and the appropriateness of medical terms. Participants:
    • Participants who may have conflicts of interest with the survey (i.e. participants employed by regulatory bodies, pharmaceutical companies).
    • Participants who have a condition that prevents them from becoming pregnant and having children.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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
    2021-01-10
    Actual study completion date
    2022-31-03

    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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