Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study
Abstract Introduction Atopic dermatitis (AD) is a chronic disease that occurs mainly in children. Topical corticosteroids are the main treatment for mild to moderate AD, although they can induce side effects. The efficacy and tolerability of xyloglucan and pea protein (XG-PP) was compared with hydro...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2023-09-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-023-01035-6 |
| _version_ | 1797647425137016832 |
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| author | Mehdi Sowlati Silviu-Horia Morariu Olguta Orzan Stefano Veraldi Roni P. Dodiuk-Gad Remus I. Orasan Cristian Gainaru |
| author_facet | Mehdi Sowlati Silviu-Horia Morariu Olguta Orzan Stefano Veraldi Roni P. Dodiuk-Gad Remus I. Orasan Cristian Gainaru |
| author_sort | Mehdi Sowlati |
| collection | DOAJ |
| description | Abstract Introduction Atopic dermatitis (AD) is a chronic disease that occurs mainly in children. Topical corticosteroids are the main treatment for mild to moderate AD, although they can induce side effects. The efficacy and tolerability of xyloglucan and pea protein (XG-PP) was compared with hydrocortisone in pediatric patients with AD as a steroid-sparing solution. Methods A prospective, multicenter, comparative study enrolled 42 patients (age 0.5–12 years) with mild-to-moderate AD, assigned 1:1 to XG-PP or hydrocortisone ointment. Treatments were applied twice daily for 14 consecutive days and assessed at baseline, day 8, and day 15. Efficacy endpoints were AD Severity Index (ADSI) score, Scoring Atopic Dermatitis (SCORAD) index, and Patient-Oriented Eczema Measure (POEM). Tolerability was assessed by the occurrence of adverse events (AEs). Results Both treatments significantly improved ADSI mean score from baseline to day 15; in the XG-PP arm, ADSI score decreased from 10.55 to 4.15 (p = 0.00001), and in the hydrocortisone arm, from 10.65 to 4.30 (p = 0.0001). In the XG-PP arm, the mean SCORAD score decreased from 65.86 to 30.26 (p = 0.00001) and in the hydrocortisone arm from 68.84 to 31.19 (p = 0.0001) at day 15. An overall decrease from moderate to mild AD for both arms (p = 0.0001) was observed with POEM. For all the three indexes evaluated, no statistical significant differences between the study arms evolution from baseline to day 8 or to day 15 were found. No AEs were reported. Conclusion XG-PP provided a comparable efficacy to hydrocortisone ointment in managing AD, thus representing a safe and effective steroid-sparing alternative in pediatric patients with AD. Trial Registration Retrospectively registered on 24 November 2021 in the ISRCTN registry: 11118799. |
| first_indexed | 2024-03-11T15:16:09Z |
| format | Article |
| id | doaj.art-bc8b634a704645fe89a8006399223548 |
| institution | Directory Open Access Journal |
| issn | 2193-8210 2190-9172 |
| language | English |
| last_indexed | 2024-03-11T15:16:09Z |
| publishDate | 2023-09-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Dermatology and Therapy |
| spelling | doaj.art-bc8b634a704645fe89a80063992235482023-10-29T12:15:07ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722023-09-0113112669267910.1007/s13555-023-01035-6Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical StudyMehdi Sowlati0Silviu-Horia Morariu1Olguta Orzan2Stefano Veraldi3Roni P. Dodiuk-Gad4Remus I. Orasan5Cristian Gainaru6County Emergency Clinica Hospital “Sf. Apostol Andrei”Mures County Clinical HospitalElias University Emergency HospitalDepartment of Pathophysiology and Transplantation, Università degli Studi, Foundation IRCCS Ca’ Granda Ospedale Maggiore PoliclinicoDermatology and Venereology Department, Emek Medical CenterMedical Office of Dermatology Prof. Dr. Orasan Remus IoanFamily Medicine Dispensary Dr. Cristian GainaruAbstract Introduction Atopic dermatitis (AD) is a chronic disease that occurs mainly in children. Topical corticosteroids are the main treatment for mild to moderate AD, although they can induce side effects. The efficacy and tolerability of xyloglucan and pea protein (XG-PP) was compared with hydrocortisone in pediatric patients with AD as a steroid-sparing solution. Methods A prospective, multicenter, comparative study enrolled 42 patients (age 0.5–12 years) with mild-to-moderate AD, assigned 1:1 to XG-PP or hydrocortisone ointment. Treatments were applied twice daily for 14 consecutive days and assessed at baseline, day 8, and day 15. Efficacy endpoints were AD Severity Index (ADSI) score, Scoring Atopic Dermatitis (SCORAD) index, and Patient-Oriented Eczema Measure (POEM). Tolerability was assessed by the occurrence of adverse events (AEs). Results Both treatments significantly improved ADSI mean score from baseline to day 15; in the XG-PP arm, ADSI score decreased from 10.55 to 4.15 (p = 0.00001), and in the hydrocortisone arm, from 10.65 to 4.30 (p = 0.0001). In the XG-PP arm, the mean SCORAD score decreased from 65.86 to 30.26 (p = 0.00001) and in the hydrocortisone arm from 68.84 to 31.19 (p = 0.0001) at day 15. An overall decrease from moderate to mild AD for both arms (p = 0.0001) was observed with POEM. For all the three indexes evaluated, no statistical significant differences between the study arms evolution from baseline to day 8 or to day 15 were found. No AEs were reported. Conclusion XG-PP provided a comparable efficacy to hydrocortisone ointment in managing AD, thus representing a safe and effective steroid-sparing alternative in pediatric patients with AD. Trial Registration Retrospectively registered on 24 November 2021 in the ISRCTN registry: 11118799.https://doi.org/10.1007/s13555-023-01035-6Atopic dermatitisChildrenHydrocortisone ointmentPea proteinXyloglucan |
| spellingShingle | Mehdi Sowlati Silviu-Horia Morariu Olguta Orzan Stefano Veraldi Roni P. Dodiuk-Gad Remus I. Orasan Cristian Gainaru Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study Dermatology and Therapy Atopic dermatitis Children Hydrocortisone ointment Pea protein Xyloglucan |
| title | Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study |
| title_full | Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study |
| title_fullStr | Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study |
| title_full_unstemmed | Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study |
| title_short | Efficacy and Tolerability of a Novel Topical Treatment Containing Pea Protein and Xyloglucan in the Management of Atopic Dermatitis in Children: A Prospective, Multicenter Clinical Study |
| title_sort | efficacy and tolerability of a novel topical treatment containing pea protein and xyloglucan in the management of atopic dermatitis in children a prospective multicenter clinical study |
| topic | Atopic dermatitis Children Hydrocortisone ointment Pea protein Xyloglucan |
| url | https://doi.org/10.1007/s13555-023-01035-6 |
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