Topical vitamin B12-a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial
Summary Background Vitamin B12 is an effective scavenger of nitric oxide (NO). As the experimental application of a NO synthase inhibitor, Nω‐nitro‐l‐arginine, led to a clear decrease in pruritus and erythema in atopic dermatitis, it would be reasonable to assume a comparable effect of vitamin B12....
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| Veröffentlicht in: | British journal of dermatology (1951) 2004-05, Vol.150 (5), p.977-983 |
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| container_title | British journal of dermatology (1951) |
| container_volume | 150 |
| creator | Stücker, M. Pieck, C. Stoerb, C. Niedner, R. Hartung, J. Altmeyer, P. |
| description | Summary
Background Vitamin B12 is an effective scavenger of nitric oxide (NO). As the experimental application of a NO synthase inhibitor, Nω‐nitro‐l‐arginine, led to a clear decrease in pruritus and erythema in atopic dermatitis, it would be reasonable to assume a comparable effect of vitamin B12.
Objectives The efficacy and tolerability of a new vitamin B12 cream as a possible alternative to current therapies was examined.
Methods A prospective, randomized and placebo‐controlled phase III multicentre trial, involving 49 patients was conducted. For the treatment duration of 8 weeks, each patient applied twice daily (in the morning and evening) the vitamin B12‐containing active preparation to the affected skin areas of one side of the body and the placebo preparation to the contralateral side according to the randomization scheme.
Results On the body side treated with the vitamin B12 cream, the modified Six Area Six Sign Atopic Dermatitis score dropped to a significantly greater extent than on the placebo‐treated body side (for the investigational drug 55·34 ± 5·74 SEM, for placebo 28·87 ± 4·86 SEM, P |
| doi_str_mv | 10.1111/j.1365-2133.2004.05866.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_200057584</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>649669761</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4416-ef24379358112c837c54340d0a1f0ae0aa9e85f5ff720b2d315d02fdac1821273</originalsourceid><addsrcrecordid>eNqNUctu1DAUjRCIDoVfQBYSywQ_k8yCBS0wBVW8VGBp3XFs1YMTB9tpZ_gj_hJnZlRY4o2vr88593GKAhFckXxebCrCalFSwlhFMeYVFm1dV9t7xeLu436xwBg3JV7W7KR4FOMGY8KwwA-LEyIIXwpCF8XvKz9aBQ7d2AS9HdAZoSWgQd-idK0DjHpKViEYx-BBXaOMgDRTUKdDD8kmG0t9A27KsR-QN0gbkxXVDsHQoeRdVllbZ9NuT0Yhp31vf-kOjQ6UXvtS-SEF71xO9ZPL9XR-a6ScHfa9pWDBPS4eGHBRPznep8XXt2-uzi_Ky4-rd-evLkvFOalLbShnzZKJlhCqWtYowRnHHQZiMGgMsNStMMKYhuI17RgRHaamA0VaSmjDTotnB9088c9JxyQ3fgpDLinzqrFoRMszqD2AVPAxBm3kGGwPYScJlrNFciNnJ-TsxMzjcm-R3Gbq06P-tO5195d49CQDnh8BEPP0Ji9M2fgPruHzeBn38oC7tU7v_rsBefb-9Rxlfnng25j09o4P4YesG9YI-f3DSn7hF_W3z59WUrA_Ix--YA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>200057584</pqid></control><display><type>article</type><title>Topical vitamin B12-a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial</title><source>Oxford University Press Journals</source><source>MEDLINE</source><source>Wiley Online Library</source><creator>Stücker, M. ; Pieck, C. ; Stoerb, C. ; Niedner, R. ; Hartung, J. ; Altmeyer, P.</creator><creatorcontrib>Stücker, M. ; Pieck, C. ; Stoerb, C. ; Niedner, R. ; Hartung, J. ; Altmeyer, P.</creatorcontrib><description>Summary
Background Vitamin B12 is an effective scavenger of nitric oxide (NO). As the experimental application of a NO synthase inhibitor, Nω‐nitro‐l‐arginine, led to a clear decrease in pruritus and erythema in atopic dermatitis, it would be reasonable to assume a comparable effect of vitamin B12.
Objectives The efficacy and tolerability of a new vitamin B12 cream as a possible alternative to current therapies was examined.
Methods A prospective, randomized and placebo‐controlled phase III multicentre trial, involving 49 patients was conducted. For the treatment duration of 8 weeks, each patient applied twice daily (in the morning and evening) the vitamin B12‐containing active preparation to the affected skin areas of one side of the body and the placebo preparation to the contralateral side according to the randomization scheme.
Results On the body side treated with the vitamin B12 cream, the modified Six Area Six Sign Atopic Dermatitis score dropped to a significantly greater extent than on the placebo‐treated body side (for the investigational drug 55·34 ± 5·74 SEM, for placebo 28·87 ± 4·86 SEM, P < 0·001). At the conclusion of the study, the investigator and patients awarded mostly a ‘good’ or ‘very good’ rating to the active drug (58% and 59%, respectively) and a ‘moderate’ or ‘poor’ rating to the placebo (89% and 87%, respectively).
Conclusions Topical vitamin B12 is a new therapeutic approach in atopic dermatitis. These results document a significant superiority of vitamin B12 cream in comparison with placebo with regard to the reduction of the extent and severity of atopic dermatitis. Furthermore, the treatment was very well tolerated and involved only very low safety risks for the patients.</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/j.1365-2133.2004.05866.x</identifier><identifier>PMID: 15149512</identifier><identifier>CODEN: BJDEAZ</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>Administration, Cutaneous ; Adult ; Aged ; Allergic diseases ; atopic dermatitis ; Biological and medical sciences ; Dermatitis, Atopic - drug therapy ; Dermatitis, Atopic - pathology ; Dermatologic Agents - adverse effects ; Dermatologic Agents - therapeutic use ; Double-Blind Method ; Enzyme Inhibitors - therapeutic use ; Female ; Humans ; Immunopathology ; inducible nitric oxide synthase ; Male ; Medical sciences ; Middle Aged ; nitric oxide ; Nitric Oxide Synthase - antagonists & inhibitors ; Nitric Oxide Synthase Type II ; Patient Satisfaction ; Prospective Studies ; Severity of Illness Index ; Skin allergic diseases. Stinging insect allergies ; Treatment Outcome ; Vitamin B 12 - adverse effects ; Vitamin B 12 - therapeutic use ; vitamin B12</subject><ispartof>British journal of dermatology (1951), 2004-05, Vol.150 (5), p.977-983</ispartof><rights>2004 INIST-CNRS</rights><rights>Copyright Blackwell Scientific Publications Ltd. May 2004</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4416-ef24379358112c837c54340d0a1f0ae0aa9e85f5ff720b2d315d02fdac1821273</citedby><cites>FETCH-LOGICAL-c4416-ef24379358112c837c54340d0a1f0ae0aa9e85f5ff720b2d315d02fdac1821273</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1365-2133.2004.05866.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1365-2133.2004.05866.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27915,27916,45565,45566</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15749358$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15149512$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Stücker, M.</creatorcontrib><creatorcontrib>Pieck, C.</creatorcontrib><creatorcontrib>Stoerb, C.</creatorcontrib><creatorcontrib>Niedner, R.</creatorcontrib><creatorcontrib>Hartung, J.</creatorcontrib><creatorcontrib>Altmeyer, P.</creatorcontrib><title>Topical vitamin B12-a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background Vitamin B12 is an effective scavenger of nitric oxide (NO). As the experimental application of a NO synthase inhibitor, Nω‐nitro‐l‐arginine, led to a clear decrease in pruritus and erythema in atopic dermatitis, it would be reasonable to assume a comparable effect of vitamin B12.
Objectives The efficacy and tolerability of a new vitamin B12 cream as a possible alternative to current therapies was examined.
Methods A prospective, randomized and placebo‐controlled phase III multicentre trial, involving 49 patients was conducted. For the treatment duration of 8 weeks, each patient applied twice daily (in the morning and evening) the vitamin B12‐containing active preparation to the affected skin areas of one side of the body and the placebo preparation to the contralateral side according to the randomization scheme.
Results On the body side treated with the vitamin B12 cream, the modified Six Area Six Sign Atopic Dermatitis score dropped to a significantly greater extent than on the placebo‐treated body side (for the investigational drug 55·34 ± 5·74 SEM, for placebo 28·87 ± 4·86 SEM, P < 0·001). At the conclusion of the study, the investigator and patients awarded mostly a ‘good’ or ‘very good’ rating to the active drug (58% and 59%, respectively) and a ‘moderate’ or ‘poor’ rating to the placebo (89% and 87%, respectively).
Conclusions Topical vitamin B12 is a new therapeutic approach in atopic dermatitis. These results document a significant superiority of vitamin B12 cream in comparison with placebo with regard to the reduction of the extent and severity of atopic dermatitis. Furthermore, the treatment was very well tolerated and involved only very low safety risks for the patients.</description><subject>Administration, Cutaneous</subject><subject>Adult</subject><subject>Aged</subject><subject>Allergic diseases</subject><subject>atopic dermatitis</subject><subject>Biological and medical sciences</subject><subject>Dermatitis, Atopic - drug therapy</subject><subject>Dermatitis, Atopic - pathology</subject><subject>Dermatologic Agents - adverse effects</subject><subject>Dermatologic Agents - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Enzyme Inhibitors - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Immunopathology</subject><subject>inducible nitric oxide synthase</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>nitric oxide</subject><subject>Nitric Oxide Synthase - antagonists & inhibitors</subject><subject>Nitric Oxide Synthase Type II</subject><subject>Patient Satisfaction</subject><subject>Prospective Studies</subject><subject>Severity of Illness Index</subject><subject>Skin allergic diseases. Stinging insect allergies</subject><subject>Treatment Outcome</subject><subject>Vitamin B 12 - adverse effects</subject><subject>Vitamin B 12 - therapeutic use</subject><subject>vitamin B12</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNUctu1DAUjRCIDoVfQBYSywQ_k8yCBS0wBVW8VGBp3XFs1YMTB9tpZ_gj_hJnZlRY4o2vr88593GKAhFckXxebCrCalFSwlhFMeYVFm1dV9t7xeLu436xwBg3JV7W7KR4FOMGY8KwwA-LEyIIXwpCF8XvKz9aBQ7d2AS9HdAZoSWgQd-idK0DjHpKViEYx-BBXaOMgDRTUKdDD8kmG0t9A27KsR-QN0gbkxXVDsHQoeRdVllbZ9NuT0Yhp31vf-kOjQ6UXvtS-SEF71xO9ZPL9XR-a6ScHfa9pWDBPS4eGHBRPznep8XXt2-uzi_Ky4-rd-evLkvFOalLbShnzZKJlhCqWtYowRnHHQZiMGgMsNStMMKYhuI17RgRHaamA0VaSmjDTotnB9088c9JxyQ3fgpDLinzqrFoRMszqD2AVPAxBm3kGGwPYScJlrNFciNnJ-TsxMzjcm-R3Gbq06P-tO5195d49CQDnh8BEPP0Ji9M2fgPruHzeBn38oC7tU7v_rsBefb-9Rxlfnng25j09o4P4YesG9YI-f3DSn7hF_W3z59WUrA_Ix--YA</recordid><startdate>200405</startdate><enddate>200405</enddate><creator>Stücker, M.</creator><creator>Pieck, C.</creator><creator>Stoerb, C.</creator><creator>Niedner, R.</creator><creator>Hartung, J.</creator><creator>Altmeyer, P.</creator><general>Blackwell Science Ltd</general><general>Blackwell</general><general>Oxford University Press</general><scope>BSCLL</scope><scope>IQODW</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>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>200405</creationdate><title>Topical vitamin B12-a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial</title><author>Stücker, M. ; Pieck, C. ; Stoerb, C. ; Niedner, R. ; Hartung, J. ; Altmeyer, P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4416-ef24379358112c837c54340d0a1f0ae0aa9e85f5ff720b2d315d02fdac1821273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Administration, Cutaneous</topic><topic>Adult</topic><topic>Aged</topic><topic>Allergic diseases</topic><topic>atopic dermatitis</topic><topic>Biological and medical sciences</topic><topic>Dermatitis, Atopic - drug therapy</topic><topic>Dermatitis, Atopic - pathology</topic><topic>Dermatologic Agents - adverse effects</topic><topic>Dermatologic Agents - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Enzyme Inhibitors - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Immunopathology</topic><topic>inducible nitric oxide synthase</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>nitric oxide</topic><topic>Nitric Oxide Synthase - antagonists & inhibitors</topic><topic>Nitric Oxide Synthase Type II</topic><topic>Patient Satisfaction</topic><topic>Prospective Studies</topic><topic>Severity of Illness Index</topic><topic>Skin allergic diseases. Stinging insect allergies</topic><topic>Treatment Outcome</topic><topic>Vitamin B 12 - adverse effects</topic><topic>Vitamin B 12 - therapeutic use</topic><topic>vitamin B12</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Stücker, M.</creatorcontrib><creatorcontrib>Pieck, C.</creatorcontrib><creatorcontrib>Stoerb, C.</creatorcontrib><creatorcontrib>Niedner, R.</creatorcontrib><creatorcontrib>Hartung, J.</creatorcontrib><creatorcontrib>Altmeyer, P.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>British journal of dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Stücker, M.</au><au>Pieck, C.</au><au>Stoerb, C.</au><au>Niedner, R.</au><au>Hartung, J.</au><au>Altmeyer, P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Topical vitamin B12-a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2004-05</date><risdate>2004</risdate><volume>150</volume><issue>5</issue><spage>977</spage><epage>983</epage><pages>977-983</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><coden>BJDEAZ</coden><abstract>Summary
Background Vitamin B12 is an effective scavenger of nitric oxide (NO). As the experimental application of a NO synthase inhibitor, Nω‐nitro‐l‐arginine, led to a clear decrease in pruritus and erythema in atopic dermatitis, it would be reasonable to assume a comparable effect of vitamin B12.
Objectives The efficacy and tolerability of a new vitamin B12 cream as a possible alternative to current therapies was examined.
Methods A prospective, randomized and placebo‐controlled phase III multicentre trial, involving 49 patients was conducted. For the treatment duration of 8 weeks, each patient applied twice daily (in the morning and evening) the vitamin B12‐containing active preparation to the affected skin areas of one side of the body and the placebo preparation to the contralateral side according to the randomization scheme.
Results On the body side treated with the vitamin B12 cream, the modified Six Area Six Sign Atopic Dermatitis score dropped to a significantly greater extent than on the placebo‐treated body side (for the investigational drug 55·34 ± 5·74 SEM, for placebo 28·87 ± 4·86 SEM, P < 0·001). At the conclusion of the study, the investigator and patients awarded mostly a ‘good’ or ‘very good’ rating to the active drug (58% and 59%, respectively) and a ‘moderate’ or ‘poor’ rating to the placebo (89% and 87%, respectively).
Conclusions Topical vitamin B12 is a new therapeutic approach in atopic dermatitis. These results document a significant superiority of vitamin B12 cream in comparison with placebo with regard to the reduction of the extent and severity of atopic dermatitis. Furthermore, the treatment was very well tolerated and involved only very low safety risks for the patients.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>15149512</pmid><doi>10.1111/j.1365-2133.2004.05866.x</doi><tpages>7</tpages></addata></record> |
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| source | Oxford University Press Journals; MEDLINE; Wiley Online Library |
| subjects | Administration, Cutaneous Adult Aged Allergic diseases atopic dermatitis Biological and medical sciences Dermatitis, Atopic - drug therapy Dermatitis, Atopic - pathology Dermatologic Agents - adverse effects Dermatologic Agents - therapeutic use Double-Blind Method Enzyme Inhibitors - therapeutic use Female Humans Immunopathology inducible nitric oxide synthase Male Medical sciences Middle Aged nitric oxide Nitric Oxide Synthase - antagonists & inhibitors Nitric Oxide Synthase Type II Patient Satisfaction Prospective Studies Severity of Illness Index Skin allergic diseases. Stinging insect allergies Treatment Outcome Vitamin B 12 - adverse effects Vitamin B 12 - therapeutic use vitamin B12 |
| title | Topical vitamin B12-a new therapeutic approach in atopic dermatitis-evaluation of efficacy and tolerability in a randomized placebo-controlled multicentre clinical trial |
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