Stepwise approach of development of dermo‐cosmetic products in healthy and atopic dermatitis paediatric population: safety evaluation, clinical development and postmarket surveillance
| Autor: | Virginie Ribet, P.‐J. Ferret, E. Brinio, M. Gurdak, A.B. Rossi, F. Giordano Labadie |
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| Rok vydání: | 2019 |
| Předmět: |
Consumer Product Safety
medicine.medical_specialty media_common.quotation_subject Population Postmarketing surveillance Cosmetics Dermatology Dermatitis Atopic 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Product Surveillance Postmarketing medicine Humans Allergy and Eczema Child Intensive care medicine education media_common education.field_of_study business.industry Infant Guideline Atopic dermatitis Middle Aged medicine.disease Infectious Diseases 030228 respiratory system Case-Control Studies Child Preschool Good clinical practice Original Article business Contact dermatitis |
| Zdroj: | Journal of the European Academy of Dermatology and Venereology |
| ISSN: | 1468-3083 0926-9959 |
| DOI: | 10.1111/jdv.15785 |
| Popis: | Background/objectives Paediatric skin, considered sensitive, and infant skin, more susceptible to percutaneous toxicity, require specially formulated cosmetic products. As recently shown, early use of emollients in infants “at risk” of developing atopic dermatitis has shown controversial results in reducing the incidence of atopic dermatitis. Development of dermo‐cosmetic products for this specific population should especially ensure tolerance and safety. In absence of good clinical practice guideline, we propose here a stepwise approach for the development of paediatric cosmetic skincare products. Methods Our stepwise methodology for cosmetics aimed at paediatrics, starts with in vitro assessment of product's ingredients safety, followed by preclinical and clinical evaluations of the final product, including sequentially: (1) Repeated Open Application Test (ROAT), (2) Human Repeated Insult Patch Test (HRIPT), (3) In‐use dermatological and ophthalmological tolerance studies (sequentially in 3a: healthy adults, 3b: healthy paediatric subjects and finally 3c: paediatric patients). We also describe the integrated cosmetovigilance–toxicological surveillance during the clinical development phase and postmarketing. Results As illustrated with one dermo‐cosmetic product intended to be used as a preventative/maintenance treatment for atopic dermatitis in paediatric population, we show that using this stepwise methodology to test a product reduces potential risks of irritation and contact dermatitis in this sensitive population. Conclusion Standardized ethical stepwise development approach is needed to ensure the commercialization of safe and well‐tolerated dermo‐cosmetics for paediatrics. The approach described here could potentially serve as guidance for evaluation of new paediatric cosmetic products. |
| Databáze: | OpenAIRE |
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