Dataset Information

Effects of a Protocol Combining a Non-Irritating Shampoo and an Adelmidrol-Based Adsorbent Mousse on Seborrhoea and Other Signs and Symptoms Secondary to Canine Atopic Dermatitis: A Multicenter, Open-Label Uncontrolled Clinical Trial.

ABSTRACT: The present study aimed at evaluating the effect of a gentle shampoo and a mousse containing Adelmidrol, tapioca starch and a non-prescription antimicrobial complex on seborrhoea and other clinical signs secondary to canine atopic dermatitis (cAD). Forty-six dogs with cAD-associated seborrhoea and/or pruritus > 4 cm on the pruritus visual analogue scale (P-VAS) and/or bacterial/Malassezia overgrowth were enrolled. The mousse was applied twice daily, and dogs were evaluated at days (D)0, 7, 14 and optionally 28, by means of a skin seborrheic index (SSI), P-VAS, cAD lesion index (CADLI), and a semiquantitative cytological score. The mean SSI value improved during the first two weeks (4.1 ± 0.37 to 1.9 ± 0.30; p < 0.0001). The mean P-VAS score (cm) decreased from 6.6 ± 0.19 at D0 to 3.8 ± 0.31 at D14 (p < 0.0001). The mean CADLI score dropped from 13.7 ± 1.24 to 8.5 ± 1.14 at D14 (p < 0.001). The cytological score for bacteria and Malassezia decreased from 3.2 ± 0.10 and 3.2 ± 0.11, respectively, to 1.2 ± 0.19 and 1.2 ± 0.24 (p < 0.0001). All the investigated signs further improved at D28. Altogether, these observations suggest that the tested protocol might be useful in managing cAD-associated signs.

SUBMITTER: Noli C

PROVIDER: S-EPMC11209480 | biostudies-literature | 2024 May

REPOSITORIES: biostudies-literature

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Effects of a Protocol Combining a Non-Irritating Shampoo and an Adelmidrol-Based Adsorbent Mousse on Seborrhoea and Other Signs and Symptoms Secondary to Canine Atopic Dermatitis: A Multicenter, Open-Label Uncontrolled Clinical Trial.

Noli Chiara C Morelli Giada G Della Valle Maria Federica MF Schievano Carlo C Skinalia Clinical Research Group

Veterinary sciences 20240521 6

The present study aimed at evaluating the effect of a gentle shampoo and a mousse containing Adelmidrol, tapioca starch and a non-prescription antimicrobial complex on seborrhoea and other clinical signs secondary to canine atopic dermatitis (cAD). Forty-six dogs with cAD-associated seborrhoea and/or pruritus > 4 cm on the pruritus visual analogue scale (P-VAS) and/or bacterial/<i>Malassezia</i> overgrowth were enrolled. The mousse was applied twice daily, and dogs were evaluated at days (D)0, 7 ...[more]

PMID: 38921976

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Project description:BackgroundDupilumab (monoclonal antibody inhibiting IL-4/IL-13 signalling) is approved for use in adolescents aged ≥ 12 years with inadequately controlled moderate-to-severe atopic dermatitis (AD). Dupilumab significantly improved AD signs/symptoms in a 16-week, randomised, placebo-controlled phase III trial in adolescents (NCT03054428).ObjectivesTo characterize the pharmacokinetics of dupilumab, and long-term safety and efficacy in adolescents.MethodsThis was a global, multicentre, phase IIa, open-label, ascending-dose, sequential cohort study with a phase III open-label extension (OLE) in adolescents with moderate-to-severe AD. In the phase IIa study, patients received one dupilumab dose (2 mg kg-1 or 4 mg kg-1 ) and 8 weeks of pharmacokinetic sampling. Thereafter, patients received the same dose weekly for 4 weeks, with 8-week safety follow-up. Patients then enrolled in the OLE, continuing 2 mg kg-1 or 4 mg kg-1 dupilumab weekly. Primary end points were dupilumab concentration-time profile and incidence of treatment-emergent adverse events (TEAEs). Secondary outcomes included Eczema Area and Severity Index (EASI).ResultsForty adolescents received dupilumab in the phase IIa study; 36 enrolled in the OLE. Dupilumab showed nonlinear, target-mediated pharmacokinetics. Mean ± SD trough dupilumab concentrations in serum at week 48 (OLE) were 74 ± 19 mg L-1 and 161 ± 60 mg L-1 for 2 mg kg-1 and 4 mg kg-1 , respectively. Dupilumab was well tolerated over 52 weeks; the most common TEAEs were nasopharyngitis (week 52: 41% [2 mg kg-1 ], 47% [4 mg kg-1 ]) and AD exacerbation (29%, 42%). After one dupilumab dose in the phase IIa study, EASI improved from baseline to week 2 [mean ± SD reduction -34% ± 20% (2 mg kg-1 ) and -51% ± 29% (4 mg kg-1 )]. With continuing treatment, EASI scores improved further [week 52: -85% ± 12% (2 mg kg-1 ) and -84% ± 20% (4 mg kg-1 )].ConclusionsIn adolescents with moderate-to-severe AD, dupilumab's pharmacokinetic profile was similar to that in adults. These 52-week safety and efficacy data support long-term use of dupilumab in this patient population. What's already known about this topic? Adolescents with moderate-to-severe atopic dermatitis (AD) have high unmet medical need, with significant disease burden and limited treatment options. Dupilumab (monoclonal antibody against interleukin-4 receptor α) is approved for the treatment of adolescents with moderate-to-severe AD who are inadequately responsive to standard of care (U.S.A.) or candidates for systemic therapy (European Union). A 16-week, randomized, placebo-controlled phase III trial in adolescents demonstrated significant improvements in AD signs/symptoms with an acceptable safety profile. What does this study add? These studies demonstrate the long-term safety and efficacy of dupilumab in adolescents with moderate-to-severe AD for up to 52 weeks of treatment, thus extending and reinforcing the findings from the 16-week dupilumab phase III trial. The data from these studies also support the use of dupilumab in combination with current standard of care (topical corticosteroids), which was not evaluated in the 16-week phase III monotherapy trial.

Project description:BACKGROUND:Skin barrier dysfunction plays a key role in atopic dermatitis (AD). This impairment is related to altered composition and metabolism of epidermal sphingolipids and a deficiency of ceramides. Glycosaminoglycans (GAGs), and especially hyaluronic acid, could be useful in the management of AD. This study aimed to evaluate the effects of a novel topical treatment consisting of sphingolipids and GAGs extracts in dogs with AD. This formulation is different from previously tested products because the sphingolipid extract contained high amounts of sphingomyelin, a precursor of ceramides, and this has been shown to enhance endogenous synthesis of ceramides and to increase lamellar-related structures in vitro. Thus, it was hypothesized that this formulation could improve clinical disease and skin barrier function in patients with AD. RESULTS:Twelve house dust mite (HDM) allergic atopic beagle dogs were randomized into two groups: control (n = 6; no treatment) or treatment (n = 6; topical sphingolipids and GAGs twice weekly for 8 weeks). Dogs were challenged with allergen twice weekly and the severity of dermatitis was scored using the canine atopic dermatitis and extent severity index (CADESI-03) once weekly. Skin barrier function (measurement of transepidermal water loss) and severity of pruritus (both pruritus visual analog scale [PVAS] and pruritus timed episodes) were assessed at 0, 4 and 8 weeks of treatment. Assessments were done by personnel unaware of group allocation. Complete blood count, serum biochemistry and stratum corneum (SC) lipidomics analyses were done at baseline and at week 8. Compared to baseline, significant increases in CADESI (P = 0.0003) and PVAS (P = 0.041) were observed only in the control group, and SC polyunsaturated fatty acids increased significantly only with treatment (P = 0.039). Compared to control, treatment group had a significantly lower CADESI after 1 week (P = 0.0078) and a significantly lower PVAS after 8 weeks (P = 0.0448). Treatment was well tolerated. CONCLUSIONS:In this study in dogs with AD, a new topical formulation containing sphingomyelin-rich sphingolipids plus GAGs extracts attenuated the clinical worsening induced by HDM, supporting its use in atopic patients, either as an adjunctive treatment or used as monotherapy in certain cases.

Project description:BackgroundAtopic dermatitis (AD) is one of the most common cutaneous inflammatory and pruritic diseases in dogs. Considering its multifactorial nature, AD can be a challenging disease to manage, and the therapeutic strategy must often be multimodal. In recent years, research has been moving toward the use of natural products which have beneficial effects on inflammation and itching, and no side effects. Cannabinoid receptors have been demonstrated to be expressed in healthy and diseased skin; therefore, one of the potential alternative therapeutic targets for investigating AD is the endocannabinoid system (ECS).ObjectiveTo immunohistochemically investigate the expression of the cannabinoid receptor type 2 (CB2R), and the cannabinoid-related receptors G protein-coupled receptor 55 (GPR55), transient receptor potential vanilloid 1 (TRPV1) and ankyrin 1 (TRPA1) in mast cells (MCs), macrophages, dendritic cells (DCs), T cells, and neutrophils of the skin of dogs with AD.AnimalsSamples of skin tissues were collected from eight dogs with AD (AD-dogs).Materials and methodsThe immunofluorescent stained cryosections of the skins of 8 dogs with AD having antibodies against CB2R, GPR55, TRPV1, TRPA1 were semiquantitatively evaluated. The inflammatory cells were identified using antibodies against tryptase (mast cells), ionized calcium binding adaptor molecule 1 (IBA1) (macrophages/DCs), CD3 (T cells), and calprotectin (neutrophils). The proportions of MCs, macrophages/DCs, T cells, and neutrophils expressing CB2R, GPR55, TRPV1 and TRPA1 were evaluated.ResultsThe cells of the inflammatory infiltrate showed immunoreactivity (IR) for all or for some of the cannabinoid and cannabinoid-related receptors studied. In particular, MCs and macrophages/DCs showed CB2R-, GPR55-, TRPA1-, and TRPV1-IR; T cells showed CB2R-, GPR55- and TRPA1-IR, and neutrophils expressed GPR55-IR. Co-localization studies indicated that CB2R-IR was co-expressed with TRPV1-, TRPA1-, and GPR55-IR in different cellular elements of the dermis of the AD-dogs.Conclusions and clinical importanceCannabinoid receptor 2, and cannabinoid-related receptors GPR55, TRPV1 and TRPA1 were widely expressed in the inflammatory infiltrate of the AD-dogs. Based on the present findings, the ECS could be considered to be a potential therapeutic target for dogs with AD, and may mitigate itch and inflammation.

Dataset Information

Effects of a Protocol Combining a Non-Irritating Shampoo and an Adelmidrol-Based Adsorbent Mousse on Seborrhoea and Other Signs and Symptoms Secondary to Canine Atopic Dermatitis: A Multicenter, Open-Label Uncontrolled Clinical Trial.

Publications

Effects of a Protocol Combining a Non-Irritating Shampoo and an Adelmidrol-Based Adsorbent Mousse on Seborrhoea and Other Signs and Symptoms Secondary to Canine Atopic Dermatitis: A Multicenter, Open-Label Uncontrolled Clinical Trial.

Similar Datasets

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