Pain relief and protection of three self-treated dermatological foot conditions

CASE STUDY TYPE

Non-Interventional Clinical Investigation Class 2a Medical Device

BACKGROUND

Prolonged compression and/or friction of the skin results in pathological increase of skin thickness (e.g. corn, callus) that may cause severe pain and discomfort. Hydrocolloid occlusive dressings (CE marketed medical devices) rehydrate the hard skin, leading to maceration, thus facilitating removal of dead skin. They could be indicated in providing pain/discomfort relief, protection, and cushioning of dermatological foot conditions self-treated with over-the-counter products.

This non-interventional clinical investigation was planned to confirm in real-life setting the clinical performances of several hydrocolloid plasters in providing pain/discomfort relief, protection, and cushion against rubbing/frictions of in patients with non-serious self-treated foot conditions.

METHODS

Non-interventional, confirmatory, post-marketing clinical follow-up (PMCF), multi-center, longitudinal study.
The goal was to enrol 1,232 patients in 100 sites in Metropolitan France.

OBJECTIVES

PRIMARY OBJECTIVE

Instant pain/discomfort relief

SECONDARY OBJECTIVES

Pain/discomfort relief
Pressure relief
Duration
Softening
Prevention of condition worsening
Cushioning
Adhesion
Usability
Global perception/satisfaction
Safety

SCIENTIFIC and DATA vALORISATION

1 Clinical Study Report (ISO14155:2020 template)
3 Clinical Evaluation Report (CER) updates performed by another provider (CER are key reports to update each product CE marking dossier)
1 Scientific publication ongoing Q2 2023
Overall excellent client satisfaction, acknowledgment and trust

Key factors of success

ICTA’s expertise in methodology/study design
ICTA’s capability to propose innovative solutions for unusual projects
ICTA’s responsiveness and flexibility

LESSONS LEARNED to speed up the start-up phase of the next study

Adaptability: Learn to work and communicate with a Sponsor who has a marketing-based culture rather than a scientific-based one
Optimal project coordination: Reporting tools implementation, community pharmacies management
Learn to communicate and coordinate investigators not experienced with clinical investigations

CHALLENGES

KEY CHALLENGES	ICTA’s SOLUTIONS	ICTA’s ACHIEVEMENTS
Compliance with MDR requirements and Sponsor requirements to collect data useful for each of their product Clinical Evaluation Report (CER)	Study documents prepared based on ISO14155 guidelines Focus on several products and claims to provide valid and reliable data to Sponsor (see below)	Preparation of study document templates based on ISO14155:2020 1 CSR and 3 CER
Sponsors’ multiple requests during kick-off meeting, e.g.: · Three studied medical conditions · Numerous objectives/endpoints to address multiple claims · Several products to test · Need for individual results per product Specific subpopulations (elderly, pregnant/breastfeeding, controlled diabetes)…	Appropriate non-interventional study design and methodology to address all Sponsor’s requests while keeping in mind the study feasibility in the context of the COVID-19 pandemic and vaccination period and type of targeted populations	Design and development of a real-life settings study, and homemade questionnaires to assess relevant claims
Non-serious self-treated medical conditions rarely leading in a medical consultation but regulatory requirements to have qualified investigators	. Decision to involve pharmacies as studied medical conditions are self-treated by over-the-counter products . Use of structured networks also widespread on the territory . Specific targeting of pharmacies selling as routine care at least one of the medical devices	. Among 6,000 potential pharmacies identified, selection of best candidates for participation to study: . 124 pharmacies in Metropolitan France signed contract and 36 enrolled at least one patient
Patient recruitment: Fieldwork during COVID-19 vaccination during which community pharmacies were actively involved	. Reduced study burden to facilitate contracting, enrolment and data collection procedures. . Remote study training of pharmacies adapted to pharmacists timetable. . Increased number of sites, sites contacts, incentives Extended timelines.	. The planned sample size (of 1,232 patients) was not reached: 417 patients were included but precision of primary endpoint was acceptable after analysis (6-11%).
Real-life data collection	. Use of easy to complete electronic CRF for pharmacists focused on a very limited number of key data . Use of dedicated paper patient questionnaire to facilitate patient data collection over follow-up . Planned reminders by pharmacists to contact their enrolled patients and retrieve completed patient questionnaires in order to increase study quality and robustness	. Close contact with active pharmacies leading to active engagement. . Elevated response rate (questionnaire completion) over a 20-days follow-up period. . High compliance to questionnaire completion: 96.7%-100.0% of patients completed questionnaires over the 20-days follow-up period. . Collection of robust data.