Benefits of teleconsultation in cosmetic clinical studies – Alternative and complementary to face to face studies
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Presented by: Séverine MONJANEL
Introduction The art of teleconsultation was born in the 1980s to facilitate the medical care of armed forces out in the field, and was later defined by the World Health Organisation (WHO) in 1997. Following the development of new technologies and ‘medical desertification’ in certain areas, teleconsultation experienced a considerable boom in the 2000s, which led to the French social security system making it reimbursable in 2019.
Similarly, connected beauty is taking on an increasingly important role in the world of cosmetics, including connected skincare, skin diagnostics and remote product testing.
Because of this, manufacturers and research centres are increasingly interested in these trends when proposing innovative methodologies for remote studies.
The COVID-19 pandemic forced the closure of most clinical study centres in March 2020 and accelerated the development of teleconsultation within cosmetics studies. Teleconsultation appointments with immediately available tools were quickly set up to complete ongoing studies remotely.
On the basis of this first experience and following the example set by telecommunication in the medical field, the clinical study centre EUROFINS EVIC France wanted to experiment the feasibility of conducting cosmetic clinical studies entirely remotely.
What tools are available and how can they be improved? What are the regulatory requirements, advantages and limits of this method in our practice? To answer these questions, two pilot studies were conducted.
Materials and methods
A first test study was conducted on three volunteers during the second lockdown in France. The evaluation parameters were tolerance (clinical examination) and effectiveness (clinical scoring, photographs, questionnaires). A ring light was provided to the volunteers to standardise evaluation conditions. A market product proven to have a significant effect on the skin was selected. The product, the material and the documentation (i.e. information/consent form) were sent to the volunteers by post. Calls and videos were made via a smartphone video conferencing application and data were collected by standard eCRF tool. A questionnaire was completed online by the volunteers in order to collect their level of interest in this type of study.
The second study was conducted on a panel of 20 volunteers in Autumn 2021. The evaluation parameters, tolerance and efficacy, were the same as those of the first study, but the tools were different: a more effective ring light was provided, a connected mirror and a new unique EDC (electronic data capture) tool under development for data recovery (eCRF, e-consent, online questionnaire, teleconsultation tool) were used. 95% of the volunteers gave positive feedback on the tools used, although 50% of them encountered problems during the study.
Results
These studies have highlighted the importance of the tools used in terms of ease of use, repeatability and standardisation, as well as the need to train the volunteers according to the type of study.
In the conditions of this study, the items “Crow foot wrinkles and fine lines”, “complexion homogeneity”, and “dark circles” could be evaluated and a product effect could even be highlighted.
Evaluation of “skin mattness” was more difficult in teleconsultation conditions and did not lead to relevant results although a product effect had been demonstrated under standard evaluation conditions.
Conclusion and perspectives
The use of teleconsultation appears to be an interesting tool for clinical studies in the cosmetics industry, but it must be reserved for certain applications in order to preserve the quality of the studies and to control the costs involved.
It can, however, be an interesting complement to face-to-face studies as it allows the following:
- Remote pre-selection visits to validate certain inclusion criteria
- The option to include subjects who are not available to travel to a particular location
- Hybrid studies, with inclusion and final evaluations at the centre and additional assessment times at home (first morning, every day, weekend)
- Carrying out multi-centre studies with a single investigator
- Meeting the demands of increasingly complex inclusion criteria by recruiting volunteers across a broader geography (not limited by commute)
- Facilitating remote access to investigators who are in short supply in certain specialties
A complementary study will be conducted to compare in situ and videoconference scoring, develop alternatives to touch-based or very light dependent items, validate new tools, and integrate instrumental measurements at home.
Similarly, connected beauty is taking on an increasingly important role in the world of cosmetics, including connected skincare, skin diagnostics and remote product testing.
Because of this, manufacturers and research centres are increasingly interested in these trends when proposing innovative methodologies for remote studies.
The COVID-19 pandemic forced the closure of most clinical study centres in March 2020 and accelerated the development of teleconsultation within cosmetics studies. Teleconsultation appointments with immediately available tools were quickly set up to complete ongoing studies remotely.
On the basis of this first experience and following the example set by telecommunication in the medical field, the clinical study centre EUROFINS EVIC France wanted to experiment the feasibility of conducting cosmetic clinical studies entirely remotely.
What tools are available and how can they be improved? What are the regulatory requirements, advantages and limits of this method in our practice? To answer these questions, two pilot studies were conducted.
Materials and methods
A first test study was conducted on three volunteers during the second lockdown in France. The evaluation parameters were tolerance (clinical examination) and effectiveness (clinical scoring, photographs, questionnaires). A ring light was provided to the volunteers to standardise evaluation conditions. A market product proven to have a significant effect on the skin was selected. The product, the material and the documentation (i.e. information/consent form) were sent to the volunteers by post. Calls and videos were made via a smartphone video conferencing application and data were collected by standard eCRF tool. A questionnaire was completed online by the volunteers in order to collect their level of interest in this type of study.
The second study was conducted on a panel of 20 volunteers in Autumn 2021. The evaluation parameters, tolerance and efficacy, were the same as those of the first study, but the tools were different: a more effective ring light was provided, a connected mirror and a new unique EDC (electronic data capture) tool under development for data recovery (eCRF, e-consent, online questionnaire, teleconsultation tool) were used. 95% of the volunteers gave positive feedback on the tools used, although 50% of them encountered problems during the study.
Results
These studies have highlighted the importance of the tools used in terms of ease of use, repeatability and standardisation, as well as the need to train the volunteers according to the type of study.
In the conditions of this study, the items “Crow foot wrinkles and fine lines”, “complexion homogeneity”, and “dark circles” could be evaluated and a product effect could even be highlighted.
Evaluation of “skin mattness” was more difficult in teleconsultation conditions and did not lead to relevant results although a product effect had been demonstrated under standard evaluation conditions.
Conclusion and perspectives
The use of teleconsultation appears to be an interesting tool for clinical studies in the cosmetics industry, but it must be reserved for certain applications in order to preserve the quality of the studies and to control the costs involved.
It can, however, be an interesting complement to face-to-face studies as it allows the following:
- Remote pre-selection visits to validate certain inclusion criteria
- The option to include subjects who are not available to travel to a particular location
- Hybrid studies, with inclusion and final evaluations at the centre and additional assessment times at home (first morning, every day, weekend)
- Carrying out multi-centre studies with a single investigator
- Meeting the demands of increasingly complex inclusion criteria by recruiting volunteers across a broader geography (not limited by commute)
- Facilitating remote access to investigators who are in short supply in certain specialties
A complementary study will be conducted to compare in situ and videoconference scoring, develop alternatives to touch-based or very light dependent items, validate new tools, and integrate instrumental measurements at home.