Paper:

RESUMEN CORTO - SHORT SUMMARY

A new dermatological shampoo for maintenance care in dogs containing a new purified natural ingredient called Ophytrium was developed. It was selected for its simultaneous threefold action on the skin barrier and for its high tolerance profile. In absence of specific regulation for non drug veterinary topical products, no guidelines are currently available for tolerance studies. An original protocol with increased frequency was therefore designed to test the skin compatibility under acute exposure.Twenty-four healthy adult kennel beagle dogs were randomized into two groups of twelve. The first group served as control and did not receive any application of product. The second group received two shampoos per week for three consecutive weeks. A complete physical examination was performed on days 0, 7, 14, and 21 by a veterinary dermatologist. In addition, skin was observed daily (except on Sundays), and lesions (if any) were scored according to their type, intensity, and extent. Mean scores were calculated for each group. No alteration of animals general health was detected. No differences were observed between the two groups, neither in daily mean scores evolution, nor in cumulative mean scores at the end of the study. Majority of the local findings were mild/localized/transient erythema and excoriations, and rare alopecia and papules, all likely related to normal behavior of kennel dogs. In conclusion, maintenance shampoo containing Ophytrium was safe and very well tolerated in dogs under these acute experimental conditions.

BIBLIOGRAFÍA

1. Regulation (EC) No 1223/2009 of the European Parliament and of The Council of 30 November 2009 on Cosmetic Products (recast). Available online at https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20190617

2. Ribet V, Gurdak M, Ferret PJ, Brinio E, Giordano Labadie F, Rossi AB. Stepwise approach of development of dermo-cosmetic products in healthy and atopic dermatitis (AD) paediatric population: safety evaluation, clinical development and post-market surveillance. J Eur Acad Dermatol Venereol 2019; 33(12):2319-2326.

TOLERANCE ASSESSMENT OF A NEW OPHYTRIUM-BASED SHAMPOO INTENDED FOR MAINTENANCE CARE IN DOGS