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P‐47
Successful management of canine atopic dermatitis with a plant extract: safety profile
Author(s) -
Nuttall T. J.,
Ferguson E. A.,
Littlewood J. D.,
Kelly A.
Publication year - 2004
Publication title -
veterinary dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.744
H-Index - 60
eISSN - 1365-3164
pISSN - 0959-4493
DOI - 10.1111/j.1365-3164.2004.00414_47.x
Subject(s) - medicine , placebo , adverse effect , atopic dermatitis , serology , clinical trial , surgery , dermatology , immunology , antibody , pathology , alternative medicine
This study reports safety data for Phytopica TM , a proprietary blend of standardized plant extracts, from a double‐blinded, placebo‐controlled trial for canine atopic dermatitis (AD). One hundred and twenty dogs with perennial AD were recruited on the basis of history and clinical signs, and a positive intradermal test or rFcεRIα serology to perennial allergens. Other pruritic dermatoses were eliminated by antimicrobial treatment, skin scrapes, Sarcoptes serology, flea control and a 6‐week food trial. Exclusion criteria included antimicrobial therapy within 7 days, antihistamines within 14 days, oral/topical glucocorticoids or cyclosporin within 28 days and parenteral glucocorticoids, essential fatty acids or immunotherapy within 56 days. Dogs were randomly allocated to receive placebo, 100, 200 or 400 mg/kg Phytopica TM daily for 12 weeks. A full history and physical examination was performed every 4 weeks. Investigators recorded any adverse events that either they observed and/or were reported by the owners. There were no serious adverse events attributable to Phytopica TM or the placebo. At least one adverse event considered possibly attributable to trial therapy was suffered by 10% (100 mg/kg), 24% (200 mg/kg), 42% (400 mg/kg) and 10% (placebo) of cases. These were mostly intermittent gastrointestinal disorders that required cessation of treatment in only four dogs (one each that received placebo and 200 mg/kg, and two that received 400 mg/kg). Only one dog in each of the 100 and 200 mg/kg dose groups refused the medicated food. In conclusion, Phytopica TM is palatable, well tolerated and has a good overall safety profile. Funding: Phytopharm plc.