John Libbey Eurotext

European Journal of Dermatology

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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 Volume 31, numéro 4, July-August 2021

Illustrations

  • Figure 1
  • Figure 2
  • Figure 3
  • Figure 4
  • Figure 5
Auteurs
1 KiOmed Pharma; Rue Haute Claire 4; 4040 Herstal, Belgium
2 University Hospital Brussels (UZB), Laarbeeklaan 101, 1090 Jette, Belgium
3 Eurofins-Dermscan; 114 Boulevard du 11 novembre 1918; 69100 Villeurbanne, France
4 Gredeco; 45 Boulevard Auriol; 75013 Paris, France
5 Private practice, Geneva, Switzerland
6 Full-time consultant for KiOmed Pharma at the time of the study
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Background

Injectable soft-tissue devices are increasingly used for improving skin defects and deficiencies related to ageing.

Objectives

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.

Materials & Methods

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.

Results

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.

Conclusion

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