PMID- 31287596
OWN - NLM
STAT- MEDLINE
DCOM- 20200527
LR  - 20200527
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Print)
IS  - 0926-9959 (Linking)
VI  - 33
IP  - 12
DP  - 2019 Dec
TI  - Stepwise approach of development of dermo-cosmetic products in healthy and atopic 
      dermatitis paediatric population: safety evaluation, clinical development and 
      postmarket surveillance.
PG  - 2319-2326
LID - 10.1111/jdv.15785 [doi]
AB  - 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.
CI  - (c) 2019 The Authors. Journal of the European Academy of Dermatology and 
      Venereology published by John Wiley & Sons Ltd on behalf of European Academy of 
      Dermatology and Venereology.
FAU - Ribet, V
AU  - Ribet V
AUID- ORCID: 0000-0003-2132-4517
AD  - Cosmetovigilance, Pierre Fabre Dermo-Cosmetics, Toulouse, France.
FAU - Gurdak, M
AU  - Gurdak M
AD  - Research and Development, Clinical Development Division, Pierre Fabre 
      Dermo-Cosmetics, Toulouse, France.
FAU - Ferret, P-J
AU  - Ferret PJ
AD  - Research and Development, Toxicology Division, Pierre Fabre Dermo-Cosmetics, 
      Toulouse, France.
FAU - Brinio, E
AU  - Brinio E
AD  - Cosmetovigilance, Pierre Fabre Dermo-Cosmetics, Toulouse, France.
FAU - Giordano Labadie, F
AU  - Giordano Labadie F
AD  - Department of Dermatology, Paul Sabatier University and Larrey Hospital, 
      Toulouse, France.
FAU - Rossi, A B
AU  - Rossi AB
AD  - Research and Development, Clinical Development Division, Pierre Fabre 
      Dermo-Cosmetics, Toulouse, France.
AD  - Department of Dermatology, Paul Sabatier University and Larrey Hospital, 
      Toulouse, France.
LA  - eng
GR  - Pierre Fabre Dermo-Cosmetics/
PT  - Journal Article
DEP - 20190830
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Cosmetics)
SB  - IM
MH  - Case-Control Studies
MH  - Child
MH  - Child, Preschool
MH  - Consumer Product Safety
MH  - *Cosmetics/adverse effects
MH  - Dermatitis, Atopic/*therapy
MH  - Humans
MH  - Infant
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
PMC - PMC6900091
EDAT- 2019/07/10 06:00
MHDA- 2020/05/28 06:00
PMCR- 2019/12/08
CRDT- 2019/07/10 06:00
PHST- 2018/12/17 00:00 [received]
PHST- 2019/06/18 00:00 [accepted]
PHST- 2019/07/10 06:00 [pubmed]
PHST- 2020/05/28 06:00 [medline]
PHST- 2019/07/10 06:00 [entrez]
PHST- 2019/12/08 00:00 [pmc-release]
AID - JDV15785 [pii]
AID - 10.1111/jdv.15785 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2019 Dec;33(12):2319-2326. doi: 10.1111/jdv.15785. 
      Epub 2019 Aug 30.