Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis

Ulrich R Hengge,1 Kristina Röschmann,2 Henning Candler3 1Skin Center, Düsseldorf, 2Department of Clinical Research, 3Department of Medical Affairs, G. Pohl‑Boskamp GmbH & Co. KG, Hohenlockstedt, Germany Introduction: Psoriasis is a frequent inflammatory sk...

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Autores principales: Hengge UR, Röschmann K, Candler H
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Publicado: Dove Medical Press 2017
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spelling oai:doaj.org-article:05d3f1d126074ccc8d3cce96080998c42021-12-02T00:27:03ZSingle-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis2230-326Xhttps://doaj.org/article/05d3f1d126074ccc8d3cce96080998c42017-06-01T00:00:00Zhttps://www.dovepress.com/single-center-noninterventional-clinical-trial-to-assess-the-safety-ef-peer-reviewed-article-PTThttps://doaj.org/toc/2230-326XUlrich R Hengge,1 Kristina Röschmann,2 Henning Candler3 1Skin Center, Düsseldorf, 2Department of Clinical Research, 3Department of Medical Affairs, G. Pohl‑Boskamp GmbH & Co. KG, Hohenlockstedt, Germany Introduction: Psoriasis is a frequent inflammatory skin disease affecting ~2%–3% of the population in western countries. Scaling of the psoriatic lesions is the most impairing symptom in patients with psoriasis. In contrast to conventional keratolytic treatment concepts containing salicylic acid or urea, a dimeticone-based medical device (Loyon®) removes scales in a physical way without any pharmacological effect.Objective: To assess the efficacy and tolerability of a dimeticone-based medical device in removal of scales in patients with psoriasis corporis/capitis under real-life conditions.Methods: Forty patients with psoriasis capitis or corporis were included and received once-daily treatments for 7 days. Clinical assessment of the psoriasis area severity index score (psoriasis corporis) and the psoriasis scalp severity index score (psoriasis capitis) was performed and evaluated at baseline, after 3 and 7 days of treatment. Baseline scaling scores and redness scores were calculated for two target lesions of the scalp or the body on a 5-point scale each.Results: For the primary efficacy variable scaling score, a statistically significant decrease was observed after treatment, with a relative reduction in scaling of 36.8% after 7 days of treatment within patients affected by psoriasis capitis. Treatment success was achieved in 76.8% of patients with psoriasis capitis, and time to treatment success was evaluated to be 4.14 days for these patients and 4.33 days for patients suffering from psoriasis corporis.Conclusion: In conclusion, this trial demonstrated that the dimeticone-based medical device is a safe, well-tolerated, practicable, and efficient keratolytic compound, which can be well implemented in and recommended for standard therapy of psoriasis. Keywords: psoriasis, keratolysis, scaling, PSSI, PASI  Hengge URRöschmann KCandler HDove Medical PressarticlepsoriasiskeratolysisscalingPSSIPASIDermatologyRL1-803ENPsoriasis: Targets and Therapy, Vol Volume 7, Pp 41-49 (2017)
institution DOAJ
collection DOAJ
language EN
topic psoriasis
keratolysis
scaling
PSSI
PASI
Dermatology
RL1-803
spellingShingle psoriasis
keratolysis
scaling
PSSI
PASI
Dermatology
RL1-803
Hengge UR
Röschmann K
Candler H
Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis
description Ulrich R Hengge,1 Kristina Röschmann,2 Henning Candler3 1Skin Center, Düsseldorf, 2Department of Clinical Research, 3Department of Medical Affairs, G. Pohl‑Boskamp GmbH & Co. KG, Hohenlockstedt, Germany Introduction: Psoriasis is a frequent inflammatory skin disease affecting ~2%–3% of the population in western countries. Scaling of the psoriatic lesions is the most impairing symptom in patients with psoriasis. In contrast to conventional keratolytic treatment concepts containing salicylic acid or urea, a dimeticone-based medical device (Loyon®) removes scales in a physical way without any pharmacological effect.Objective: To assess the efficacy and tolerability of a dimeticone-based medical device in removal of scales in patients with psoriasis corporis/capitis under real-life conditions.Methods: Forty patients with psoriasis capitis or corporis were included and received once-daily treatments for 7 days. Clinical assessment of the psoriasis area severity index score (psoriasis corporis) and the psoriasis scalp severity index score (psoriasis capitis) was performed and evaluated at baseline, after 3 and 7 days of treatment. Baseline scaling scores and redness scores were calculated for two target lesions of the scalp or the body on a 5-point scale each.Results: For the primary efficacy variable scaling score, a statistically significant decrease was observed after treatment, with a relative reduction in scaling of 36.8% after 7 days of treatment within patients affected by psoriasis capitis. Treatment success was achieved in 76.8% of patients with psoriasis capitis, and time to treatment success was evaluated to be 4.14 days for these patients and 4.33 days for patients suffering from psoriasis corporis.Conclusion: In conclusion, this trial demonstrated that the dimeticone-based medical device is a safe, well-tolerated, practicable, and efficient keratolytic compound, which can be well implemented in and recommended for standard therapy of psoriasis. Keywords: psoriasis, keratolysis, scaling, PSSI, PASI  
format article
author Hengge UR
Röschmann K
Candler H
author_facet Hengge UR
Röschmann K
Candler H
author_sort Hengge UR
title Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis
title_short Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis
title_full Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis
title_fullStr Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis
title_full_unstemmed Single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis
title_sort single-center, noninterventional clinical trial to assess the safety, efficacy, and tolerability of a dimeticone-based medical device in facilitating the removal of scales after topical application in patients with psoriasis corporis or psoriasis capitis
publisher Dove Medical Press
publishDate 2017
url https://doaj.org/article/05d3f1d126074ccc8d3cce96080998c4
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AT roschmannk singlecenternoninterventionalclinicaltrialtoassessthesafetyefficacyandtolerabilityofadimeticonebasedmedicaldeviceinfacilitatingtheremovalofscalesaftertopicalapplicationinpatientswithpsoriasiscorporisorpsoriasiscapitis
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