March 8, 2010 (Miami Beach, Fla.) -- A new drug called alitretinoin can help relieve cracked, itchy, irritated hands in people with severe hand eczema , researchers report.

Hands "completely or almost completely" cleared up in nearly half of people with hand eczema that didn't respond to standard treatment, says Charles Lynde, MD, assistant professor of dermatology at the University of Toronto.

Up to 10% of people have hand dermatitis , in which the skin becomes inflamed, typically from an allergic reaction to an irritant, Lynde says. The hand becomes dry and chapped and eventually red, scaly, and inflamed.

Of those, about 5% have dermatitis as severe as the people in the new research, he says.

"These were hard-core patients who weren't getting better when treated with ointments containing corticosteroids," the standard drugs used to reduce inflammation in people with severe dermatitis. They had suffered for nine or 10 years, on average, Lynde tells WebMD.

"At present, we don't have very much to offer when corticosteroid [ointments] fail," he says.

Enter alitretinoin, a relative of vitamin A that is approved for severe hand eczema in some European countries and Canada but not the U.S. It's given in capsule form, once a day.

At the annual meeting of the American Academy of Dermatology (AAD), Lynde summarized findings from three studies showing that alitretinoin is effective in a substantial proportion of these patients.

"The first and second studies show that itching , redness, fissures, and dryness go away. The third shows it will help if you relapse," he says.

The research was funded by Basilea Pharmaceutica International, which markets alitretinoin under the brand name Toctino in Europe. Lynde has reported being a consultant for Basilea.

 

Alitretinoin Clears Up Severe Hand Dermatitis

 

The largest of the studies involved 1,032 people with severe hand dermatitis in Europe and Canada. The patients took a 10-milligram or 30-milligram dose of alitretinoin, or placebo, once a day for 12 or 24 weeks.

Participants were told to avoid irritants such as detergent that could trigger or exacerbate their dermatitis.

The skin condition completely or almost completely resolved in 48% of patients treated with the higher dose of alitretinoin. "That means they were 90%, 95%, 100% improved," Lynde says.

In contrast, 28% of patients treated with the lower dose and 17% of placebo-treated patients completely or almost completely responded.

The second study involved 249 patients in Europe and Canada. All had suffered from hand eczema for years. Steroid ointments no longer worked for them, Lynde says.

All received the higher dose of alitretinoin for up to 24 weeks.

The hand rash cleared up in 47% of patients.

The third study was designed to determine if the drug could help patients who relapse after treatment with alitretinoin.

"About a third relapsed, so we tried alitretinoin again," Lynde says.

It worked, with the rash resolving in about four-fifths of patients given the 30-milligram dose. In contrast, fewer than 10% of patients given a placebo responded.

Alitretinoin doesn't work overnight -- it typically takes four to six weeks to see any change, Lynde says. And not everyone responds.

"But this does offer new hope for dermatitis we thought was incurable. Patients improve and quite a few go into remission," he says.

The most frequent side effects are headache and dryness and flushing of the skin, Lynde says. Also, it can cause serious, even fatal birth defects , so women who are pregnant or thinking about getting pregnant should never take it, he says.

Additionally, the medication can make you more sensitive to the sun, so you may burn more easily, says past AAD president Darrell S. Rigel, MD, clinical professor of dermatology at New York University Medical Center.

"On the flip side, chronic hand eczema is very hard to treat. If it’s so severe you don't want to go out in public or you’re in business and don’t want to shake hands, this appears to offer a good option," he tells WebMD.

 

WebMD Health News 
by Charlene Laino 
Reviewed By Laura Martin
Last Modified: 2010/3/8 下午 05:36:55

減緩手部濕疹的新藥

Alitretinoin能讓某些用傳統療程無效的嚴重手部濕疹患者痊癒

  【24drs.com】March 8, 2010(佛州邁阿密海灘)-- 研究人員表示,有種稱為alitretinoin的新藥能讓嚴重手部濕疹患者,裂開、發癢、疼痛的手得到舒緩。
  
  多倫多大學皮膚科助理教授Charles Lynde醫師表示,那些對於標準療程沒有反應的手部濕疹患者,有近乎一半可以讓手「完全或近乎完全」乾淨。
  
  Lynde醫師表示,多達10%的人會有手部濕疹的問題,這是一種皮膚發炎,通常是對刺激物有過敏反應,手變得乾燥與龜裂,最後變紅、鱗片狀、並紅腫。
  
  他表示,當然,約有5%的人跟這篇最新研究中的人一樣嚴重,有皮膚炎的問題。
  
  這群很難治療的患者用含有corticosteroid的軟膏治療沒有反應,這種軟膏是用來減少嚴重皮膚炎患者的發炎反應。Lynde醫師向WebMD表示,他們平均都有9、10年的病史。
  
  他表示,目前,若corticosteroid[軟膏]無效時沒有提供更多治療。
  
  與維生素A有關的alitretinoin已被一些歐洲國家與加拿大核准治療嚴重手部濕疹,但美國尚未核准,它是膠囊的型式,每天一顆。
  
  Lynde醫師在美國皮膚科學會(AAD)的年會中概述三篇研究的結果,alitretinoin對於大部份的患者都有效。
  
  他表示,第一與第二篇研究顯示,能解決發癢、紅、裂、以及乾的問題;第三篇研究顯示,對於舊疾復發時有效。
  
  這篇研究由銷售alitretinoin的Basilea國際製藥公司贊助,alitretinoin在歐洲的品牌名稱是Toctino,Lynde博士是Basilea公司的顧問。
  
  【Alitretinoin能清除嚴重手部皮膚炎】
  在歐洲與加拿大所做的這篇最大型研究,對象是1,032位有嚴重手部皮膚炎的患者,這些患者每天服用10mg alitretinoin、30mg alitretinoin、或是安慰劑,研究持續12週或24週。
  
  研究人員要求參與者避免像是洗潔劑等會誘發或惡化皮膚炎的刺激物。
  
  用較高劑量alitretinoin治療的患者,皮膚疾病完全或幾乎完全康復,Lynde醫師表示,這代表他們改善了90%、95%、100%。相對地,28%用較低劑量治療的患者與17%用安慰劑治療的患者完全或幾乎完全康復。
  
  第二篇研究是針對249位歐洲與加拿大的患者,所有人都有數年的手部濕疹病史,Lynde醫師表示,類固醇軟膏對他們都不再有效。所有人都用較高劑量alitretinoin治療24週。有47%的患者手部疹子被清除。
  
  第三篇研究是設計來確定,這種藥對於用alitretinoin治療後復發的患者是否有效,Lynde醫師表示,約有三分之一的患者復發,所以他們再次試用alitretinoin。
  
  有五分之四的患者在使用30mg的劑量後痊癒了,相對地,使用安慰劑的患者只有不到10%有反應。
  
  Lynde醫師表示,Alitretinoin不會馬上有效,通常是在4至6週後才能看出改變,而且不是對每個人都有用。
  
  但他表示,這個劑量讓一些他們認為無可救藥的患者有了新希望,患者有改善且舒緩程度相當大。
  
  Lynde博士表示,最常看到的副作用是頭痛與皮膚乾、發紅,同時,它會造成嚴重、甚至致命的天生缺陷,因此懷孕或可能懷孕的婦女絕不能使用。
  
  AAD前主席、紐約大學醫學中心皮膚科臨床教授Darrell S. Rigel醫師表示,另外,這種藥會讓你對陽光比較敏感,因此,你可能會較容易曬傷。
  
  他向WebMD表示,另外,慢性手部濕疹是非常難治療的,如果嚴重到你不想走入大眾或是你在工作時不想跟別人握手,這種藥可能是個很好的選擇。

 

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