Efficacy of ultra‐micronized palmitoylethanolamide in canine atopic dermatitis: an open‐label multi‐centre study

Abstract

Background -Palmitoylethanolamide is a naturally occurring bioactive lipid, produced on-demand by damageexposed cells. Palmitoylethanolamide is documented to counteract inflammation, itch and pain.Objective -The aim of this 8-week study was to evaluate the efficacy of oral ultra-micronized palmitoylethanolamide (PEA-um) in dogs with moderate atopic dermatitis.Animals -Clinicians from 39 veterinary clinics enrolled 160 dogs with nonseasonal atopic dermatitis and moderate pruritus.Methods -This was a multi-centre open-label study. On days 0 (D0) and 56 (D56), owners evaluated pruritus with a Visual Analog Scale (VAS) and completed a validated Quality of Life (QoL) questionnaire. Veterinarians assessed the severity of skin lesions using the Canine Atopic Dermatitis Lesion Index (CADLI).Results -Mean pruritus VAS score decreased from 5.7 AE 0.08 cm (range 3.8-7.9 cm) to 3.63 AE 0.19 cm (range 0.1-9.2 cm) (P < 0.0001). At D56, 58% of dogs showed a greater than 2 cm reduction from baseline and 30% showed an absent-to-very mild pruritus (VAS ≤ 2 cm). Mean total CADLI at D56 decreased significantly (P < 0.0001); in 62% of dogs this score reached a value in the remission range (≤5). Mean total QoL score was significantly decreased (P < 0.0001) with 45% of dogs reaching QoL values described for healthy animals. Tolerability was good-to-excellent with only four dogs reporting treatment associated reversible adverse events.Conclusions and clinical importance -PEA-um appears to be effective and safe in reducing pruritus and skin lesions, and in improving QoL in dogs with moderate atopic dermatitis and moderate pruritus.

Impact of a terbinafine–florfenicol–betamethasone acetate otic gel on the quality of life of dogs with acute otitis externa and their owners

“…A similar discrepancy between improvements in values for QoL1 and QoL2, after clinically successful therapy courses, has been described in dogs and cats treated for allergic dermatitis . A further confirmation of this hypothesis could come from the analysis of the answers to the single questions of the QoL questionnaire: the conventional treatment protocol did not lead to any score improvement related to therapy administration (questions 8, 9 and 10).…”

“…Expensive, time consuming, tiresome or difficult treatments can also negatively affect the QoL of owners and their pets. Therefore, an improvement of the clinical parameters induced by the therapy does not necessarily result in a similar improvement of QoL of patients and owners, as previously observed in skin diseases in dogs and cats . For this reason, the evaluation of QoL should always be performed in parallel with the assessment of clinical parameters in studies investigating therapeutic efficacy.…”

Ultramicronized palmitoylethanolamide counteracts the effects of compound 48/80 in a canine skin organ culture model

“…Although further studies on the present ex vivo model are merited, one should keep in mind that PEA‐um has been reported to decrease MC‐derived vasoactive mediators, both in vitro and in vivo . Moreover, the effect of systemic administration of PEA‐um on clinical signs sustained by dilation of cutaneous capillary vessels, including erythema, and the wheal and flare reaction, has been demonstrated in dogs …”

“…In the present ex vivo model, exposing skin organ cultures to PEA‐um for 96 h did not elicit any change in either the epidermal or dermal skin compartments, in terms of epidermal thickness or keratinocyte proliferation, the same pattern of keratinocyte differentiation markers, unchanged MC density and degranulation state, compared to vehicle‐treated samples. These findings are consistent with results of previous studies on the lack of PEA‐um cytotoxicity and its overall in vivo safety profile …”

“…These include a protective role of PEA against skin inflammation in different in vivo models of allergic dermatitis . An open‐label clinical study demonstrated the efficacy of orally administered ultramicronized PEA (PEA‐um, a formulation of PEA with smaller particle size) in reducing pruritus and skin lesions in dogs affected with AD …”