A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial
Federica Dall’Oglio, Anna Elisa Verzì, Giulia Guglielmi, Sabrina Zappulla, Giuseppe Micali Dermatology Clinic, University of Catania, Catania, ItalyCorrespondence: Giuseppe Micali, Dermatology Clinic, University of Catania, Via S. Sofia 78, Catania, 95123, Italy, Tel +39 095 321705, Fax +39 095 3782...
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Dove Medical Press
2024-11-01
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| Series: | Psoriasis: Targets and Therapy |
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| author | Dall'Oglio F Verzì AE Guglielmi G Zappulla S Micali G |
| author_facet | Dall'Oglio F Verzì AE Guglielmi G Zappulla S Micali G |
| author_sort | Dall'Oglio F |
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| description | Federica Dall’Oglio, Anna Elisa Verzì, Giulia Guglielmi, Sabrina Zappulla, Giuseppe Micali Dermatology Clinic, University of Catania, Catania, ItalyCorrespondence: Giuseppe Micali, Dermatology Clinic, University of Catania, Via S. Sofia 78, Catania, 95123, Italy, Tel +39 095 321705, Fax +39 095 3782425, Email cldermct@gmail.comPurpose: Psoriasis affecting sensitive areas and folds represents a therapeutic challenging as the skin in these areas may be more prone to local pharmacological side effects. The aim of this prospective, randomized, open-label study was to evaluate the efficacy and tolerability of a new prescription emollient device (PED) as a cream containing primarily furfuryl palmitate (antioxidant, anti-inflammatory, soothing), tocopherol (antioxidant), and dimethicone (occlusive) for the treatment of psoriasis localized to difficult-to-treat areas.Patients and Methods: Thirty patients (14M/16F) with mild-to-moderate psoriasis of sensitive areas such as face, vulva, scrotum, pubic area, neck (15 cases), and of folds including axillary fossa, intergluteal cleft, submammary/inguinal folds, and umbilicus (15 cases) were consecutively enrolled and instructed to apply the cream twice daily for 8 weeks. Efficacy was assessed at baseline, at 4 and 8 weeks by measuring the degree of erythema, scaling, infiltration and pruritus using clinical, instrumental and subject-completed Visual Analog Scale (VAS) assessments. At the end of the study, the Investigator Global Assessment (IGA) of efficacy was performed.Results: Statistically significant reductions in erythema, scaling, infiltration, and itching scores were observed at 8 weeks compared to baseline. In addition, IGA efficacy score was clear in 7 cases and almost clear in 4 cases for psoriasis of sensitive areas and clear in 5 cases and almost clear in 4 cases for psoriasis of folds. No relevant side effects were observed in any of the groups.Conclusion: Our results suggest that the tested PED containing antioxidant, anti-inflammatory, soothing and occlusive agents may represent a valid therapeutic option for mild-to-moderate psoriasis of sensitive areas and folds in monotherapy or in combination with pharmacological agents if necessary.Keywords: topical treatment, medical device, furfuryl palmitate, steroid-sparing cream |
| format | Article |
| id | doaj-art-d9f02c794cda4b72822f6c9d6428382e |
| institution | Kabale University |
| issn | 2230-326X |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Dove Medical Press |
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| series | Psoriasis: Targets and Therapy |
| spelling | doaj-art-d9f02c794cda4b72822f6c9d6428382e2024-11-14T17:37:44ZengDove Medical PressPsoriasis: Targets and Therapy2230-326X2024-11-01Volume 1413514297329A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open TrialDall'Oglio FVerzì AEGuglielmi GZappulla SMicali GFederica Dall’Oglio, Anna Elisa Verzì, Giulia Guglielmi, Sabrina Zappulla, Giuseppe Micali Dermatology Clinic, University of Catania, Catania, ItalyCorrespondence: Giuseppe Micali, Dermatology Clinic, University of Catania, Via S. Sofia 78, Catania, 95123, Italy, Tel +39 095 321705, Fax +39 095 3782425, Email cldermct@gmail.comPurpose: Psoriasis affecting sensitive areas and folds represents a therapeutic challenging as the skin in these areas may be more prone to local pharmacological side effects. The aim of this prospective, randomized, open-label study was to evaluate the efficacy and tolerability of a new prescription emollient device (PED) as a cream containing primarily furfuryl palmitate (antioxidant, anti-inflammatory, soothing), tocopherol (antioxidant), and dimethicone (occlusive) for the treatment of psoriasis localized to difficult-to-treat areas.Patients and Methods: Thirty patients (14M/16F) with mild-to-moderate psoriasis of sensitive areas such as face, vulva, scrotum, pubic area, neck (15 cases), and of folds including axillary fossa, intergluteal cleft, submammary/inguinal folds, and umbilicus (15 cases) were consecutively enrolled and instructed to apply the cream twice daily for 8 weeks. Efficacy was assessed at baseline, at 4 and 8 weeks by measuring the degree of erythema, scaling, infiltration and pruritus using clinical, instrumental and subject-completed Visual Analog Scale (VAS) assessments. At the end of the study, the Investigator Global Assessment (IGA) of efficacy was performed.Results: Statistically significant reductions in erythema, scaling, infiltration, and itching scores were observed at 8 weeks compared to baseline. In addition, IGA efficacy score was clear in 7 cases and almost clear in 4 cases for psoriasis of sensitive areas and clear in 5 cases and almost clear in 4 cases for psoriasis of folds. No relevant side effects were observed in any of the groups.Conclusion: Our results suggest that the tested PED containing antioxidant, anti-inflammatory, soothing and occlusive agents may represent a valid therapeutic option for mild-to-moderate psoriasis of sensitive areas and folds in monotherapy or in combination with pharmacological agents if necessary.Keywords: topical treatment, medical device, furfuryl palmitate, steroid-sparing creamhttps://www.dovepress.com/a-new-prescription-emollient-device-ped-for-psoriasis-of-sensitive-are-peer-reviewed-fulltext-article-PTTtopical treatmentmedical devicefurfuryl palmitatesteroid-sparing cream |
| spellingShingle | Dall'Oglio F Verzì AE Guglielmi G Zappulla S Micali G A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial Psoriasis: Targets and Therapy topical treatment medical device furfuryl palmitate steroid-sparing cream |
| title | A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial |
| title_full | A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial |
| title_fullStr | A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial |
| title_full_unstemmed | A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial |
| title_short | A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial |
| title_sort | new prescription emollient device ped for psoriasis of sensitive areas and folds a randomized prospective open trial |
| topic | topical treatment medical device furfuryl palmitate steroid-sparing cream |
| url | https://www.dovepress.com/a-new-prescription-emollient-device-ped-for-psoriasis-of-sensitive-are-peer-reviewed-fulltext-article-PTT |
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