Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double‐blind, randomized, vehicle‐controlled study
Introduction Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (acti...
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| Veröffentlicht in: | Journal of cosmetic dermatology 2023-07, Vol.22 (7), p.2050-2053 |
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| creator | Massiot, Philippe Pinto, Pedro Contreiras Leclerc‐Mercier, Stephanie Rasmont, Virginie Piraccini, Bianca Maria Rudnicka, Lidia Reygagne, Pascal Melo, Daniel Fernandes Vano‐Galvan, Sergio Wu, Wen‐Yu Kerob, Delphine |
| description | Introduction
Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis‐prone scalp.
Objective
To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis.
Materials and methods
A single‐center, randomized, double‐blind, vehicle‐controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis–specific quality‐of‐life issues using SCALPDEX and product acceptability.
Results
The active shampoo significantly (p |
| doi_str_mv | 10.1111/jocd.15693 |
| format | Article |
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Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis‐prone scalp.
Objective
To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis.
Materials and methods
A single‐center, randomized, double‐blind, vehicle‐controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis–specific quality‐of‐life issues using SCALPDEX and product acceptability.
Results
The active shampoo significantly (p < 0.05) reduced the PSSI by 39.0%, 37.2%, 63.0%, and 69.0% immediately after washing compared to a 22.8%, 5.5%, 19.6%, and 13.0% with the vehicle at Days 1, 8, 15, and 30, respectively. SCALPDEX items, IGA, and irritation significantly (p < 0.05) reduced with the active shampoo. Hair and scalp greasiness improved continuously with both products until Day 21. Subject‐reported symptom scores paralleled the positive evolution of clinical signs. The active shampoo was well tolerated, subjects were highly satisfied and had an improved QoL.
Conclusion
The active shampoo significantly improved clinical signs, symptoms, and QoL of mild‐to‐moderate scalp psoriasis compared to the vehicle. It was very well tolerated and highly appreciated by the subjects.</description><identifier>ISSN: 1473-2130</identifier><identifier>EISSN: 1473-2165</identifier><identifier>DOI: 10.1111/jocd.15693</identifier><identifier>PMID: 36942745</identifier><language>eng</language><publisher>England: John Wiley & Sons, Inc</publisher><subject>Adult ; Conflicts of interest ; Consent ; Dermatitis ; Dermatologic Agents - therapeutic use ; dermocosmetic ; Double-Blind Method ; Excipients ; Hair Preparations - adverse effects ; Humans ; Immunoglobulin A - therapeutic use ; Inflammation ; Keratolytic Agents - adverse effects ; Psoriasis ; Psoriasis - diagnosis ; Psoriasis - drug therapy ; Quality of Life ; randomized double‐blind study ; salicylic acid ; scalp ; Scalp Dermatoses - diagnosis ; Scalp Dermatoses - drug therapy ; Side effects ; Steroids ; Treatment Outcome</subject><ispartof>Journal of cosmetic dermatology, 2023-07, Vol.22 (7), p.2050-2053</ispartof><rights>2023 The Authors. published by Wiley Periodicals LLC.</rights><rights>2023 The Authors. Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.</rights><rights>2023. This work is published under http://creativecommons.org/licenses/by/4.0/ (the "License"). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3933-601083a07daa74b144ed99c393abe08a6e9135c3a6253a513a8bbffc4092bec93</citedby><cites>FETCH-LOGICAL-c3933-601083a07daa74b144ed99c393abe08a6e9135c3a6253a513a8bbffc4092bec93</cites><orcidid>0000-0003-2816-4261 ; 0000-0003-1803-3006 ; 0000-0002-8807-2556</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjocd.15693$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjocd.15693$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,1416,11560,27922,27923,45572,45573,46050,46474</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36942745$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Massiot, Philippe</creatorcontrib><creatorcontrib>Pinto, Pedro Contreiras</creatorcontrib><creatorcontrib>Leclerc‐Mercier, Stephanie</creatorcontrib><creatorcontrib>Rasmont, Virginie</creatorcontrib><creatorcontrib>Piraccini, Bianca Maria</creatorcontrib><creatorcontrib>Rudnicka, Lidia</creatorcontrib><creatorcontrib>Reygagne, Pascal</creatorcontrib><creatorcontrib>Melo, Daniel Fernandes</creatorcontrib><creatorcontrib>Vano‐Galvan, Sergio</creatorcontrib><creatorcontrib>Wu, Wen‐Yu</creatorcontrib><creatorcontrib>Kerob, Delphine</creatorcontrib><title>Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double‐blind, randomized, vehicle‐controlled study</title><title>Journal of cosmetic dermatology</title><addtitle>J Cosmet Dermatol</addtitle><description>Introduction
Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis‐prone scalp.
Objective
To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis.
Materials and methods
A single‐center, randomized, double‐blind, vehicle‐controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis–specific quality‐of‐life issues using SCALPDEX and product acceptability.
Results
The active shampoo significantly (p < 0.05) reduced the PSSI by 39.0%, 37.2%, 63.0%, and 69.0% immediately after washing compared to a 22.8%, 5.5%, 19.6%, and 13.0% with the vehicle at Days 1, 8, 15, and 30, respectively. SCALPDEX items, IGA, and irritation significantly (p < 0.05) reduced with the active shampoo. Hair and scalp greasiness improved continuously with both products until Day 21. Subject‐reported symptom scores paralleled the positive evolution of clinical signs. The active shampoo was well tolerated, subjects were highly satisfied and had an improved QoL.
Conclusion
The active shampoo significantly improved clinical signs, symptoms, and QoL of mild‐to‐moderate scalp psoriasis compared to the vehicle. It was very well tolerated and highly appreciated by the subjects.</description><subject>Adult</subject><subject>Conflicts of interest</subject><subject>Consent</subject><subject>Dermatitis</subject><subject>Dermatologic Agents - therapeutic use</subject><subject>dermocosmetic</subject><subject>Double-Blind Method</subject><subject>Excipients</subject><subject>Hair Preparations - adverse effects</subject><subject>Humans</subject><subject>Immunoglobulin A - therapeutic use</subject><subject>Inflammation</subject><subject>Keratolytic Agents - adverse effects</subject><subject>Psoriasis</subject><subject>Psoriasis - diagnosis</subject><subject>Psoriasis - drug therapy</subject><subject>Quality of Life</subject><subject>randomized double‐blind study</subject><subject>salicylic acid</subject><subject>scalp</subject><subject>Scalp Dermatoses - diagnosis</subject><subject>Scalp Dermatoses - drug therapy</subject><subject>Side effects</subject><subject>Steroids</subject><subject>Treatment Outcome</subject><issn>1473-2130</issn><issn>1473-2165</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp9kUtuFDEQhi1ERMLAhgMgS2wQygx2ux_jJZoQIIoUCcHa8qOa8eC2B7s7UbPKEXKknIWTxD2TZMEi3rhU9flTyT9CbyhZ0Hw-boI2C1rVnD1DR7Rs2LygdfX8sWbkEL1MaUMIbTitXqBDVvOyaMrqCN2unPVWS4cVeGhtj6U3uA8OovQa8DaG1jrAocUS_87NPBp7q3fYejS5Yf0vnNay24aArcdpUBvQfcJXtl_jzrpJh7tgpsdZmEK0Mtm0wN8hDS6DbQxdtpswKAf_rm9UXskc47yACZ39C7m-hLXVu6EOvo_BOTA49YMZX6GDVroEr-_vGfp5-vnH6uv8_OLLt9Wn87lmnLF5TShZMkkaI2VTKlqWYDifZlIBWcoaOGWVZrIuKiYryuRSqbbVJeGFAs3ZDL3fe_OP_Bkg9aKzSYNz0kMYkiiaJS9YXWTNDL37D92EIfq8nWCEk5qyomky9WFP6RhSitCKbbSdjKOgREy5iilXscs1w2_vlYPqwDyiD0FmgO6Bq5zW-IRKnF2sTvbSO9Bxs3Q</recordid><startdate>202307</startdate><enddate>202307</enddate><creator>Massiot, Philippe</creator><creator>Pinto, Pedro Contreiras</creator><creator>Leclerc‐Mercier, Stephanie</creator><creator>Rasmont, Virginie</creator><creator>Piraccini, Bianca Maria</creator><creator>Rudnicka, Lidia</creator><creator>Reygagne, Pascal</creator><creator>Melo, Daniel Fernandes</creator><creator>Vano‐Galvan, Sergio</creator><creator>Wu, Wen‐Yu</creator><creator>Kerob, Delphine</creator><general>John Wiley & Sons, Inc</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-2816-4261</orcidid><orcidid>https://orcid.org/0000-0003-1803-3006</orcidid><orcidid>https://orcid.org/0000-0002-8807-2556</orcidid></search><sort><creationdate>202307</creationdate><title>Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double‐blind, randomized, vehicle‐controlled study</title><author>Massiot, Philippe ; Pinto, Pedro Contreiras ; Leclerc‐Mercier, Stephanie ; Rasmont, Virginie ; Piraccini, Bianca Maria ; Rudnicka, Lidia ; Reygagne, Pascal ; Melo, Daniel Fernandes ; Vano‐Galvan, Sergio ; Wu, Wen‐Yu ; Kerob, Delphine</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3933-601083a07daa74b144ed99c393abe08a6e9135c3a6253a513a8bbffc4092bec93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Conflicts of interest</topic><topic>Consent</topic><topic>Dermatitis</topic><topic>Dermatologic Agents - therapeutic use</topic><topic>dermocosmetic</topic><topic>Double-Blind Method</topic><topic>Excipients</topic><topic>Hair Preparations - adverse effects</topic><topic>Humans</topic><topic>Immunoglobulin A - therapeutic use</topic><topic>Inflammation</topic><topic>Keratolytic Agents - adverse effects</topic><topic>Psoriasis</topic><topic>Psoriasis - diagnosis</topic><topic>Psoriasis - drug therapy</topic><topic>Quality of Life</topic><topic>randomized double‐blind study</topic><topic>salicylic acid</topic><topic>scalp</topic><topic>Scalp Dermatoses - diagnosis</topic><topic>Scalp Dermatoses - drug therapy</topic><topic>Side effects</topic><topic>Steroids</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Massiot, Philippe</creatorcontrib><creatorcontrib>Pinto, Pedro Contreiras</creatorcontrib><creatorcontrib>Leclerc‐Mercier, Stephanie</creatorcontrib><creatorcontrib>Rasmont, Virginie</creatorcontrib><creatorcontrib>Piraccini, Bianca Maria</creatorcontrib><creatorcontrib>Rudnicka, Lidia</creatorcontrib><creatorcontrib>Reygagne, Pascal</creatorcontrib><creatorcontrib>Melo, Daniel Fernandes</creatorcontrib><creatorcontrib>Vano‐Galvan, Sergio</creatorcontrib><creatorcontrib>Wu, Wen‐Yu</creatorcontrib><creatorcontrib>Kerob, Delphine</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of cosmetic dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Massiot, Philippe</au><au>Pinto, Pedro Contreiras</au><au>Leclerc‐Mercier, Stephanie</au><au>Rasmont, Virginie</au><au>Piraccini, Bianca Maria</au><au>Rudnicka, Lidia</au><au>Reygagne, Pascal</au><au>Melo, Daniel Fernandes</au><au>Vano‐Galvan, Sergio</au><au>Wu, Wen‐Yu</au><au>Kerob, Delphine</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double‐blind, randomized, vehicle‐controlled study</atitle><jtitle>Journal of cosmetic dermatology</jtitle><addtitle>J Cosmet Dermatol</addtitle><date>2023-07</date><risdate>2023</risdate><volume>22</volume><issue>7</issue><spage>2050</spage><epage>2053</epage><pages>2050-2053</pages><issn>1473-2130</issn><eissn>1473-2165</eissn><abstract>Introduction
Scalp psoriasis frequently goes with other disease location and may lead to a significant burden and impairment of quality of life (QoL). Adherence to local treatments is a frequent problem. A keratolytic and hydrating shampoo containing 2% salicylic acid, 5% urea, and 1% glycerin (active shampoo) has been developed for psoriasis‐prone scalp.
Objective
To assess the efficacy and tolerability of an active shampoo in subjects with mild to moderate scalp psoriasis.
Materials and methods
A single‐center, randomized, double‐blind, vehicle‐controlled study was conducted on 67 adults with mild to moderate psoriasis. The active shampoo or its vehicle were applied daily for 14 days and 3 times/week for another 14 days. Assessments included the Psoriasis Scalp Severity Index (PSSI), Investigator Global Assessment (IGA), calculated total surface affected hair, scalp greasiness, irritation, and assessed scalp dermatitis–specific quality‐of‐life issues using SCALPDEX and product acceptability.
Results
The active shampoo significantly (p < 0.05) reduced the PSSI by 39.0%, 37.2%, 63.0%, and 69.0% immediately after washing compared to a 22.8%, 5.5%, 19.6%, and 13.0% with the vehicle at Days 1, 8, 15, and 30, respectively. SCALPDEX items, IGA, and irritation significantly (p < 0.05) reduced with the active shampoo. Hair and scalp greasiness improved continuously with both products until Day 21. Subject‐reported symptom scores paralleled the positive evolution of clinical signs. The active shampoo was well tolerated, subjects were highly satisfied and had an improved QoL.
Conclusion
The active shampoo significantly improved clinical signs, symptoms, and QoL of mild‐to‐moderate scalp psoriasis compared to the vehicle. It was very well tolerated and highly appreciated by the subjects.</abstract><cop>England</cop><pub>John Wiley & Sons, Inc</pub><pmid>36942745</pmid><doi>10.1111/jocd.15693</doi><tpages>4</tpages><orcidid>https://orcid.org/0000-0003-2816-4261</orcidid><orcidid>https://orcid.org/0000-0003-1803-3006</orcidid><orcidid>https://orcid.org/0000-0002-8807-2556</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Conflicts of interest Consent Dermatitis Dermatologic Agents - therapeutic use dermocosmetic Double-Blind Method Excipients Hair Preparations - adverse effects Humans Immunoglobulin A - therapeutic use Inflammation Keratolytic Agents - adverse effects Psoriasis Psoriasis - diagnosis Psoriasis - drug therapy Quality of Life randomized double‐blind study salicylic acid scalp Scalp Dermatoses - diagnosis Scalp Dermatoses - drug therapy Side effects Steroids Treatment Outcome |
| title | Clinical benefit and tolerance profile of a keratolytic and hydrating shampoo in subjects with mild to moderate psoriasis. Results from a double‐blind, randomized, vehicle‐controlled study |
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