A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study
No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures. To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients wi...
Gespeichert in:
| Veröffentlicht in: | Journal of the American Academy of Dermatology 2023-07, Vol.89 (1), p.62-69 |
|---|---|
| Hauptverfasser: | , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 69 |
|---|---|
| container_issue | 1 |
| container_start_page | 62 |
| container_title | Journal of the American Academy of Dermatology |
| container_volume | 89 |
| creator | Fujimoto, Tomoko Terahara, Takaaki Okawa, Koji Inakura, Hiroshi Hirayama, Yuta Yokozeki, Hiroo |
| description | No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures.
To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients with primary palmar hyperhidrosis (PPHH).
In a randomized controlled trial, Japanese patients with PPHH aged 12 years and older received either 20% OL (n = 144) or placebo (n = 140) on both palms once daily for 4 weeks. Palmar sweat volume was measured by the ventilated capsule method. For the primary outcome, response was defined as a reduction of sweat volume of at least 50% from baseline.
At week 4, the responder rate for sweat volume was significantly higher in the 20% OL arm than in the placebo arm (52.8% vs 24.3%, respectively; treatment difference, 28.5% [95% CI, 17.7% to 39.3%]; P |
| doi_str_mv | 10.1016/j.jaad.2023.03.025 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2792902794</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S019096222300511X</els_id><sourcerecordid>2792902794</sourcerecordid><originalsourceid>FETCH-LOGICAL-c356t-3b134ca380971d54de0ffb2e7d5d129a9dc4e5e995715fde6e3e7d08bb2705eb3</originalsourceid><addsrcrecordid>eNp9kcuKFDEUhoMoTjv6Ai4kG8HFVJukbh2ZTTN4aRhwo-uQyykqTSppk9Qw5Tv5jqbs1qVwyAnJ9_9wzo_Qa0q2lNDu_XF7lNJsGWH1lpRi7RO0oYT3Vdfv-qdoQygnFe8Yu0IvUjoSQnhT98_RVd1xTmpGNujXHvvwAA67kG3weAhxmp38cw8DZuQtDo-LmvPircfjYmLQowvRGlhZnEfAOYLME_i8Kk7RTjIu-CRd6UVxgjjaIks2fcB7HKU3YbI_wdzgk5MaVKh08DkG59Y3E2bloFLO-pUYZQJ8OBxwyrNZXqJng3QJXl36Nfr-6eO3uy_V_dfPh7v9faXrtstVrWjdaFnvyi6oaRsDZBgUg960hjIuudENtMB529N2MNBBXf7ITinWkxZUfY3enX1PMfyYIWUx2aTBOekhzEmwnjNOytkUlJ1RXUZMEQZx2YCgRKwxiaNYYxJrTIKUYm0Rvbn4z2oC80_yN5cC3J4BKFM-WIgiaQteg7ERdBYm2P_5_wZQKqdj</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2792902794</pqid></control><display><type>article</type><title>A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study</title><source>Access via ScienceDirect (Elsevier)</source><creator>Fujimoto, Tomoko ; Terahara, Takaaki ; Okawa, Koji ; Inakura, Hiroshi ; Hirayama, Yuta ; Yokozeki, Hiroo</creator><creatorcontrib>Fujimoto, Tomoko ; Terahara, Takaaki ; Okawa, Koji ; Inakura, Hiroshi ; Hirayama, Yuta ; Yokozeki, Hiroo</creatorcontrib><description>No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures.
To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients with primary palmar hyperhidrosis (PPHH).
In a randomized controlled trial, Japanese patients with PPHH aged 12 years and older received either 20% OL (n = 144) or placebo (n = 140) on both palms once daily for 4 weeks. Palmar sweat volume was measured by the ventilated capsule method. For the primary outcome, response was defined as a reduction of sweat volume of at least 50% from baseline.
At week 4, the responder rate for sweat volume was significantly higher in the 20% OL arm than in the placebo arm (52.8% vs 24.3%, respectively; treatment difference, 28.5% [95% CI, 17.7% to 39.3%]; P < .001). No serious adverse events occurred, and no adverse events led to treatment discontinuation.
The treatment period was only 4 weeks.
In patients with PPHH, 20% OL is superior to placebo in reducing palmar sweat volume.</description><identifier>ISSN: 0190-9622</identifier><identifier>EISSN: 1097-6787</identifier><identifier>DOI: 10.1016/j.jaad.2023.03.025</identifier><identifier>PMID: 36990320</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Hyperhidrosis Disease Severity Scale (HDSS) ; oxybutynin hydrochloride ; perspiration meter ; primary palmar hyperhidrosis ; sweat volume ; ventilated capsule method</subject><ispartof>Journal of the American Academy of Dermatology, 2023-07, Vol.89 (1), p.62-69</ispartof><rights>2023 American Academy of Dermatology, Inc.</rights><rights>Copyright © 2023 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c356t-3b134ca380971d54de0ffb2e7d5d129a9dc4e5e995715fde6e3e7d08bb2705eb3</citedby><cites>FETCH-LOGICAL-c356t-3b134ca380971d54de0ffb2e7d5d129a9dc4e5e995715fde6e3e7d08bb2705eb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jaad.2023.03.025$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36990320$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fujimoto, Tomoko</creatorcontrib><creatorcontrib>Terahara, Takaaki</creatorcontrib><creatorcontrib>Okawa, Koji</creatorcontrib><creatorcontrib>Inakura, Hiroshi</creatorcontrib><creatorcontrib>Hirayama, Yuta</creatorcontrib><creatorcontrib>Yokozeki, Hiroo</creatorcontrib><title>A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study</title><title>Journal of the American Academy of Dermatology</title><addtitle>J Am Acad Dermatol</addtitle><description>No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures.
To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients with primary palmar hyperhidrosis (PPHH).
In a randomized controlled trial, Japanese patients with PPHH aged 12 years and older received either 20% OL (n = 144) or placebo (n = 140) on both palms once daily for 4 weeks. Palmar sweat volume was measured by the ventilated capsule method. For the primary outcome, response was defined as a reduction of sweat volume of at least 50% from baseline.
At week 4, the responder rate for sweat volume was significantly higher in the 20% OL arm than in the placebo arm (52.8% vs 24.3%, respectively; treatment difference, 28.5% [95% CI, 17.7% to 39.3%]; P < .001). No serious adverse events occurred, and no adverse events led to treatment discontinuation.
The treatment period was only 4 weeks.
In patients with PPHH, 20% OL is superior to placebo in reducing palmar sweat volume.</description><subject>Hyperhidrosis Disease Severity Scale (HDSS)</subject><subject>oxybutynin hydrochloride</subject><subject>perspiration meter</subject><subject>primary palmar hyperhidrosis</subject><subject>sweat volume</subject><subject>ventilated capsule method</subject><issn>0190-9622</issn><issn>1097-6787</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9kcuKFDEUhoMoTjv6Ai4kG8HFVJukbh2ZTTN4aRhwo-uQyykqTSppk9Qw5Tv5jqbs1qVwyAnJ9_9wzo_Qa0q2lNDu_XF7lNJsGWH1lpRi7RO0oYT3Vdfv-qdoQygnFe8Yu0IvUjoSQnhT98_RVd1xTmpGNujXHvvwAA67kG3weAhxmp38cw8DZuQtDo-LmvPircfjYmLQowvRGlhZnEfAOYLME_i8Kk7RTjIu-CRd6UVxgjjaIks2fcB7HKU3YbI_wdzgk5MaVKh08DkG59Y3E2bloFLO-pUYZQJ8OBxwyrNZXqJng3QJXl36Nfr-6eO3uy_V_dfPh7v9faXrtstVrWjdaFnvyi6oaRsDZBgUg960hjIuudENtMB529N2MNBBXf7ITinWkxZUfY3enX1PMfyYIWUx2aTBOekhzEmwnjNOytkUlJ1RXUZMEQZx2YCgRKwxiaNYYxJrTIKUYm0Rvbn4z2oC80_yN5cC3J4BKFM-WIgiaQteg7ERdBYm2P_5_wZQKqdj</recordid><startdate>202307</startdate><enddate>202307</enddate><creator>Fujimoto, Tomoko</creator><creator>Terahara, Takaaki</creator><creator>Okawa, Koji</creator><creator>Inakura, Hiroshi</creator><creator>Hirayama, Yuta</creator><creator>Yokozeki, Hiroo</creator><general>Elsevier Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202307</creationdate><title>A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study</title><author>Fujimoto, Tomoko ; Terahara, Takaaki ; Okawa, Koji ; Inakura, Hiroshi ; Hirayama, Yuta ; Yokozeki, Hiroo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c356t-3b134ca380971d54de0ffb2e7d5d129a9dc4e5e995715fde6e3e7d08bb2705eb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Hyperhidrosis Disease Severity Scale (HDSS)</topic><topic>oxybutynin hydrochloride</topic><topic>perspiration meter</topic><topic>primary palmar hyperhidrosis</topic><topic>sweat volume</topic><topic>ventilated capsule method</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fujimoto, Tomoko</creatorcontrib><creatorcontrib>Terahara, Takaaki</creatorcontrib><creatorcontrib>Okawa, Koji</creatorcontrib><creatorcontrib>Inakura, Hiroshi</creatorcontrib><creatorcontrib>Hirayama, Yuta</creatorcontrib><creatorcontrib>Yokozeki, Hiroo</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American Academy of Dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fujimoto, Tomoko</au><au>Terahara, Takaaki</au><au>Okawa, Koji</au><au>Inakura, Hiroshi</au><au>Hirayama, Yuta</au><au>Yokozeki, Hiroo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study</atitle><jtitle>Journal of the American Academy of Dermatology</jtitle><addtitle>J Am Acad Dermatol</addtitle><date>2023-07</date><risdate>2023</risdate><volume>89</volume><issue>1</issue><spage>62</spage><epage>69</epage><pages>62-69</pages><issn>0190-9622</issn><eissn>1097-6787</eissn><abstract>No previous controlled studies have been specifically designed or adequately powered to show the efficacy of topical oxybutynin for palmar hyperhidrosis by using quantitative measures.
To evaluate efficacy of 20% oxybutynin hydrochloride lotion (20% OL) in reducing palmar sweat volume in patients with primary palmar hyperhidrosis (PPHH).
In a randomized controlled trial, Japanese patients with PPHH aged 12 years and older received either 20% OL (n = 144) or placebo (n = 140) on both palms once daily for 4 weeks. Palmar sweat volume was measured by the ventilated capsule method. For the primary outcome, response was defined as a reduction of sweat volume of at least 50% from baseline.
At week 4, the responder rate for sweat volume was significantly higher in the 20% OL arm than in the placebo arm (52.8% vs 24.3%, respectively; treatment difference, 28.5% [95% CI, 17.7% to 39.3%]; P < .001). No serious adverse events occurred, and no adverse events led to treatment discontinuation.
The treatment period was only 4 weeks.
In patients with PPHH, 20% OL is superior to placebo in reducing palmar sweat volume.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36990320</pmid><doi>10.1016/j.jaad.2023.03.025</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0190-9622 |
| ispartof | Journal of the American Academy of Dermatology, 2023-07, Vol.89 (1), p.62-69 |
| issn | 0190-9622 1097-6787 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2792902794 |
| source | Access via ScienceDirect (Elsevier) |
| subjects | Hyperhidrosis Disease Severity Scale (HDSS) oxybutynin hydrochloride perspiration meter primary palmar hyperhidrosis sweat volume ventilated capsule method |
| title | A novel lotion formulation of 20% oxybutynin hydrochloride for the treatment of primary palmar hyperhidrosis: A randomized, placebo-controlled, double-blind, phase III study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-25T22%3A24%3A50IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=A%20novel%20lotion%20formulation%20of%2020%25%20oxybutynin%20hydrochloride%20for%20the%20treatment%20of%20primary%20palmar%20hyperhidrosis:%20A%20randomized,%20placebo-controlled,%20double-blind,%20phase%20III%20study&rft.jtitle=Journal%20of%20the%20American%20Academy%20of%20Dermatology&rft.au=Fujimoto,%20Tomoko&rft.date=2023-07&rft.volume=89&rft.issue=1&rft.spage=62&rft.epage=69&rft.pages=62-69&rft.issn=0190-9622&rft.eissn=1097-6787&rft_id=info:doi/10.1016/j.jaad.2023.03.025&rft_dat=%3Cproquest_cross%3E2792902794%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2792902794&rft_id=info:pmid/36990320&rft_els_id=S019096222300511X&rfr_iscdi=true |