Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study
Topical calcineurin inhibitors are used off label in the treatment of vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use. This study aimed to compare the efficacy of tacrolimus 0.1% ointment with that of the vehicle for repigmentation in adult patients with fac...
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| Veröffentlicht in: | Journal of investigative dermatology 2021-07, Vol.141 (7), p.1728-1734 |
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| container_title | Journal of investigative dermatology |
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| creator | Seneschal, Julien Duplaine, Alexandra Maillard, Hervé Passeron, Thierry Andreu, Nicolas Lassalle, Régis Favary, Clélia Droitcourt, Catherine Taïeb, Alain Ezzedine, Khaled |
| description | Topical calcineurin inhibitors are used off label in the treatment of vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use.
This study aimed to compare the efficacy of tacrolimus 0.1% ointment with that of the vehicle for repigmentation in adult patients with facial vitiligo.
This study was a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension.
Participants included were adult patients with recent facial vitiligo target lesions ( |
| doi_str_mv | 10.1016/j.jid.2020.12.028 |
| format | Article |
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This study aimed to compare the efficacy of tacrolimus 0.1% ointment with that of the vehicle for repigmentation in adult patients with facial vitiligo.
This study was a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension.
Participants included were adult patients with recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the previous 3 months.
Patients received either tacrolimus 0.1% ointment or vehicle twice daily.
The primary outcome was a therapeutic success, defined as a change ≥75% in the repigmentation of the target lesion between baseline and week 24, measured by ImageJ software. Secondary outcome measures were a variation of the physicians’ global assessment scores and patients’ satisfaction scores, safety data, and the rate of relapse at week 48.
A total of 42 patients were included. Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% of vehicle-treated patients at week 24 (P < 0.0001). Only 40% of relapse was observed at 48 weeks.
Twice-daily tacrolimus 0.1% ointment showed superior efficacy to that of the vehicle through the 24 weeks of intervention and 24 weeks of follow-up in adult patients with facial vitiligo.
This study was registered at ClinicalTrials.gov (identifier: NCT02466997).</description><identifier>ISSN: 0022-202X</identifier><identifier>EISSN: 1523-1747</identifier><identifier>DOI: 10.1016/j.jid.2020.12.028</identifier><identifier>PMID: 33549606</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Dermatology ; Human health and pathology ; Life Sciences</subject><ispartof>Journal of investigative dermatology, 2021-07, Vol.141 (7), p.1728-1734</ispartof><rights>2021 The Authors</rights><rights>Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.</rights><rights>Attribution - NonCommercial</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c430t-b9b81e2709df09817fd8bcd6f27bd350997d2fda08b8cfb2dc1829397a05cd743</citedby><cites>FETCH-LOGICAL-c430t-b9b81e2709df09817fd8bcd6f27bd350997d2fda08b8cfb2dc1829397a05cd743</cites><orcidid>0000-0002-5468-4589 ; 0000-0001-6714-6643 ; 0000-0002-0928-8608 ; 0000-0003-0418-1438 ; 0000-0001-6726-6215 ; 0000-0003-1139-0908 ; 0000-0002-0797-6570 ; 0000-0002-0667-9064 ; 0000-0001-9837-3670 ; 0000-0002-2122-3663</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33549606$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-03700544$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Seneschal, Julien</creatorcontrib><creatorcontrib>Duplaine, Alexandra</creatorcontrib><creatorcontrib>Maillard, Hervé</creatorcontrib><creatorcontrib>Passeron, Thierry</creatorcontrib><creatorcontrib>Andreu, Nicolas</creatorcontrib><creatorcontrib>Lassalle, Régis</creatorcontrib><creatorcontrib>Favary, Clélia</creatorcontrib><creatorcontrib>Droitcourt, Catherine</creatorcontrib><creatorcontrib>Taïeb, Alain</creatorcontrib><creatorcontrib>Ezzedine, Khaled</creatorcontrib><title>Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study</title><title>Journal of investigative dermatology</title><addtitle>J Invest Dermatol</addtitle><description>Topical calcineurin inhibitors are used off label in the treatment of vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use.
This study aimed to compare the efficacy of tacrolimus 0.1% ointment with that of the vehicle for repigmentation in adult patients with facial vitiligo.
This study was a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension.
Participants included were adult patients with recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the previous 3 months.
Patients received either tacrolimus 0.1% ointment or vehicle twice daily.
The primary outcome was a therapeutic success, defined as a change ≥75% in the repigmentation of the target lesion between baseline and week 24, measured by ImageJ software. Secondary outcome measures were a variation of the physicians’ global assessment scores and patients’ satisfaction scores, safety data, and the rate of relapse at week 48.
A total of 42 patients were included. Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% of vehicle-treated patients at week 24 (P < 0.0001). Only 40% of relapse was observed at 48 weeks.
Twice-daily tacrolimus 0.1% ointment showed superior efficacy to that of the vehicle through the 24 weeks of intervention and 24 weeks of follow-up in adult patients with facial vitiligo.
This study was registered at ClinicalTrials.gov (identifier: NCT02466997).</description><subject>Dermatology</subject><subject>Human health and pathology</subject><subject>Life Sciences</subject><issn>0022-202X</issn><issn>1523-1747</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp9kcFu1DAQhi0EotuWB-CCfEGiEllsJ1kn5bQsLUXaCgmWipvl2GPWKycutlNp-xK8Mo627ZHTaGa-_x9pfoReUzKnhC4-7OY7q-eMsNyzOWHNMzSjNSsLyiv-HM0IYazI619H6DjGHcmaqm5eoqOyrKt2QRYz9PfCGKuk2mM5aPxDGkh77A3eSBW8s_0YcTZ_i40POG0BbwLI1MOQJuhSKisdvrHJOvvbn-Mlvh5dsirvIeDv2dL39h70e_zZj52D4pOzg576G9halQcrP6R8yEE-nka9P0UvjHQRXj3UE_Tz8mKzuirW3758XS3XhapKkoqu7RoKjJNWG9I2lBvddEovDOOdLmvStlwzoyVpukaZjmlFG9aWLZekVppX5Qk6O_hupRO3wfYy7IWXVlwt12KakZITUlfVHc3suwN7G_yfEWISvY0KnJMD-DEKVjW8Yi1hPKP0gObvxRjAPHlTIqbMxE7kzMSUmaBM5Myy5s2D_dj1oJ8UjyFl4OMBgPyQOwtBRGVhUKBtAJWE9vY_9v8A0aSmjw</recordid><startdate>20210701</startdate><enddate>20210701</enddate><creator>Seneschal, Julien</creator><creator>Duplaine, Alexandra</creator><creator>Maillard, Hervé</creator><creator>Passeron, Thierry</creator><creator>Andreu, Nicolas</creator><creator>Lassalle, Régis</creator><creator>Favary, Clélia</creator><creator>Droitcourt, Catherine</creator><creator>Taïeb, Alain</creator><creator>Ezzedine, Khaled</creator><general>Elsevier Inc</general><general>Nature Publishing Group</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><orcidid>https://orcid.org/0000-0002-5468-4589</orcidid><orcidid>https://orcid.org/0000-0001-6714-6643</orcidid><orcidid>https://orcid.org/0000-0002-0928-8608</orcidid><orcidid>https://orcid.org/0000-0003-0418-1438</orcidid><orcidid>https://orcid.org/0000-0001-6726-6215</orcidid><orcidid>https://orcid.org/0000-0003-1139-0908</orcidid><orcidid>https://orcid.org/0000-0002-0797-6570</orcidid><orcidid>https://orcid.org/0000-0002-0667-9064</orcidid><orcidid>https://orcid.org/0000-0001-9837-3670</orcidid><orcidid>https://orcid.org/0000-0002-2122-3663</orcidid></search><sort><creationdate>20210701</creationdate><title>Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study</title><author>Seneschal, Julien ; Duplaine, Alexandra ; Maillard, Hervé ; Passeron, Thierry ; Andreu, Nicolas ; Lassalle, Régis ; Favary, Clélia ; Droitcourt, Catherine ; Taïeb, Alain ; Ezzedine, Khaled</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c430t-b9b81e2709df09817fd8bcd6f27bd350997d2fda08b8cfb2dc1829397a05cd743</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Dermatology</topic><topic>Human health and pathology</topic><topic>Life Sciences</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Seneschal, Julien</creatorcontrib><creatorcontrib>Duplaine, Alexandra</creatorcontrib><creatorcontrib>Maillard, Hervé</creatorcontrib><creatorcontrib>Passeron, Thierry</creatorcontrib><creatorcontrib>Andreu, Nicolas</creatorcontrib><creatorcontrib>Lassalle, Régis</creatorcontrib><creatorcontrib>Favary, Clélia</creatorcontrib><creatorcontrib>Droitcourt, Catherine</creatorcontrib><creatorcontrib>Taïeb, Alain</creatorcontrib><creatorcontrib>Ezzedine, Khaled</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><jtitle>Journal of investigative dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Seneschal, Julien</au><au>Duplaine, Alexandra</au><au>Maillard, Hervé</au><au>Passeron, Thierry</au><au>Andreu, Nicolas</au><au>Lassalle, Régis</au><au>Favary, Clélia</au><au>Droitcourt, Catherine</au><au>Taïeb, Alain</au><au>Ezzedine, Khaled</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study</atitle><jtitle>Journal of investigative dermatology</jtitle><addtitle>J Invest Dermatol</addtitle><date>2021-07-01</date><risdate>2021</risdate><volume>141</volume><issue>7</issue><spage>1728</spage><epage>1734</epage><pages>1728-1734</pages><issn>0022-202X</issn><eissn>1523-1747</eissn><abstract>Topical calcineurin inhibitors are used off label in the treatment of vitiligo, and there is a lack of placebo-controlled, blinded studies to support their use.
This study aimed to compare the efficacy of tacrolimus 0.1% ointment with that of the vehicle for repigmentation in adult patients with facial vitiligo.
This study was a 24-week multicenter randomized parallel double-blind study with a 24-week post-treatment follow-up extension.
Participants included were adult patients with recent facial vitiligo target lesions (<2 years) without changes in pigmentation or size over the previous 3 months.
Patients received either tacrolimus 0.1% ointment or vehicle twice daily.
The primary outcome was a therapeutic success, defined as a change ≥75% in the repigmentation of the target lesion between baseline and week 24, measured by ImageJ software. Secondary outcome measures were a variation of the physicians’ global assessment scores and patients’ satisfaction scores, safety data, and the rate of relapse at week 48.
A total of 42 patients were included. Therapeutic success was achieved in 65% of tacrolimus-treated patients versus 0% of vehicle-treated patients at week 24 (P < 0.0001). Only 40% of relapse was observed at 48 weeks.
Twice-daily tacrolimus 0.1% ointment showed superior efficacy to that of the vehicle through the 24 weeks of intervention and 24 weeks of follow-up in adult patients with facial vitiligo.
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| ispartof | Journal of investigative dermatology, 2021-07, Vol.141 (7), p.1728-1734 |
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| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_03700544v1 |
| source | EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Dermatology Human health and pathology Life Sciences |
| title | Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study |
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