PMID- 34463288
OWN - NLM
STAT- Publisher
LR  - 20240220
IS  - 1952-4013 (Electronic)
IS  - 1167-1122 (Linking)
DP  - 2021 Aug 26
TI  - Safety and efficacy of a carboxymethyl chitosan dermal injection device for the 
      treatment of skin defects: a first-in-man, pilot, comparative, split-body study.
LID - 10.1684/ejd.2021.4091 [doi]
AB  - Injectable soft-tissue devices are increasingly used for improving skin defects 
      and deficiencies related to ageing. To assess the safety and efficacy of KIO015, 
      a new injectable soft-tissue device formulated with carboxymethyl chitosan for 
      the intradermal treatment of skin defects associated with ageing. Twenty-two 
      subjects (40-65 years) were randomized to receive injections in the neckline of 
      KIO015 and a non-cross-linked HA-based device, and were followed for up to 10 
      months. Injection site reactions (ISRs) and adverse events (AEs) were documented. 
      Skin improvement was assessed instrumentally and clinically. Skin biopsies at 
      injection zones in the lower back were taken at Day 28 for histopathology and 
      immunohistochemistry analyses, to further assess product performance. 
      Histomorphometric analyses on rabbits and in vitro assessment of KIO015 
      antioxidant capacity were also conducted. KIO015 was very well tolerated. Only 
      expected and transient ISRs were observed; mainly erythema and hematoma. No 
      adverse local effects or foreign body granuloma were observed histologically. 
      Both clinical and instrumental evaluations confirmed the performance of KIO015. 
      The skin was firmer and more elastic. Skin hydration showed significant 
      improvement three days after injection. KIO015 exhibited superior overall 
      maintenance of skin hydration after 10 months as compared to HA. These clinical 
      results were supported by in vitro trials and implantation tests in the rabbit. 
      The results from this pilot study support the use of KIO015 as an innovative 
      alternative to HA-based devices for intradermal treatment of skin disorders.
FAU - Philippart, Catherine
AU  - Philippart C
AD  - KiOmed Pharma; Rue Haute Claire 4; 4040 Herstal, Belgium.
FAU - Hendrickx, Benoit
AU  - Hendrickx B
AD  - University Hospital Brussels (UZB), Laarbeeklaan 101, 1090 Jette, Belgium.
FAU - Rharbaoui, Siham
AU  - Rharbaoui S
AD  - Eurofins-Dermscan; 114 Boulevard du 11 novembre 1918; 69100 Villeurbanne, France.
FAU - Natalizio, Audrey
AU  - Natalizio A
AD  - Eurofins-Dermscan; 114 Boulevard du 11 novembre 1918; 69100 Villeurbanne, France.
FAU - Boisnic, Sylvie
AU  - Boisnic S
AD  - Gredeco; 45 Boulevard Auriol; 75013 Paris, France.
FAU - Micheels, Patrick
AU  - Micheels P
AD  - Private practice, Geneva, Switzerland.
FAU - Gautier, Sandrine
AU  - Gautier S
AD  - KiOmed Pharma; Rue Haute Claire 4; 4040 Herstal, Belgium.
FAU - Douette, Pierre
AU  - Douette P
AD  - Full-time consultant for KiOmed Pharma at the time of the study.
FAU - Hermitte, Laurence
AU  - Hermitte L
AD  - KiOmed Pharma; Rue Haute Claire 4; 4040 Herstal, Belgium.
LA  - eng
PT  - Journal Article
DEP - 20210826
PL  - France
TA  - Eur J Dermatol
JT  - European journal of dermatology : EJD
JID - 9206420
SB  - IM
OTO - NOTNLM
OT  - ageing skin
OT  - carboxymethyl chitosan
OT  - injectable soft-tissue device
OT  - non-animal origin
EDAT- 2021/09/01 06:00
MHDA- 2021/09/01 06:00
CRDT- 2021/08/31 09:00
PHST- 2021/08/31 09:00 [entrez]
PHST- 2021/09/01 06:00 [pubmed]
PHST- 2021/09/01 06:00 [medline]
AID - ejd.2021.4091 [pii]
AID - 10.1684/ejd.2021.4091 [doi]
PST - aheadofprint
SO  - Eur J Dermatol. 2021 Aug 26. doi: 10.1684/ejd.2021.4091.