你的容貌是否为脸颊和前额的暗疮而苦恼？或是否深受黑斑病的困扰？
 
不用担心，全球首支治疗药品Tri-Luma面膏将为您解决这一面部难题。
 
Tri-Luma面膏含有三种活性成分——氟轻松,对苯二酚,维甲酸是治疗短期或间歇性中度及重度黑斑病的特效药，安全有效，疗效非常显著，使用8个星期，还你亮丽容颜！

Tri-Luma Cream汰膚斑乳膏资料

成份：氟轻松安奈德0.01％，4％氢醌，维甲酸0.05％

Tri-Luma™ Cream说明书

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研究显示：三联乳膏对黑斑病治疗及各型皮肤均有益

一项采用新疗法（PIGMENT试验）治疗黑斑病的社区前瞻性调查进一步表明，由0.01%氟轻松、4%氢醌和0.05%维A酸组成的三联乳膏（Tri-Luma Cream）治疗黑斑病安全高效。

研究发现，用药后皮损迅速改善，适用于临床各种皮肤类型患者日常使用，并能显著改善患者的生活质量。开放性PIGMENT IV期临床试验包括1290名患者，年龄18-84岁，Fitzpatrick皮肤分型I-IV型，中重度黑斑病病程至少3个月。研究对象主要是女性（占96%）和高加索人(n=800,62%),但也包括相当多的其他人种，如非裔美国人（n=130，10.1%），亚洲人（n=94,7.3%）和西班牙人（n=295,22.9%）。所有患者均避免日光照射，黑斑局部应用三联乳膏，每天一次，共8周。按计划于4周后开始随访，直至治疗结束。大约有500名调查者参与了该项研究。以黑斑面积和严重指数（Melasma Area and Severity Index,MASI）的变化为主要疗效终点，

PIGMENT试验的结果表明，首次随访时，三联乳膏治疗者明显改善，随后的4周治疗后，症状继续改善。将患者按种族或Fitzpatrick皮肤分型分类，各亚组患者的MASI得分均明显下降。

采用研究者总体评定作为一个次级结果测定指标，其结果进一步确证了三联乳膏的疗效。在基线处和8周后完成的生活质量问卷应答分析显示，三联乳膏治疗对患者生活质量产生了显著的积极作用。安全性评价显示，三联乳膏耐受性良好，不良反应发生率低。没有皮肤萎缩的病例报道，因不良反应退出研究的少（占3%）。PIGMENT试验结果支持这一确定性结论，即该Kligman处方样三联乳膏治疗黑斑病作用迅速，疗效可靠。

自约30年前Kligman医生介绍剂型以来，皮肤病学家们一直在合成他们自己的剂型，但结果常以失败告终。俄亥俄州Medina的私人诊所医生、PIGMENT试验的研究者Torok医生说：“PIGMENT试验结果和上市前研究证实了该剂型含有氢醌、氟轻松和维A酸，并确保了各成分的稳定性和治疗靶部位的生物利用度，该产品已能从市场上买到。”她继续说：“另外有一点很重要，上市前研究阐明了三联乳膏治疗I-IV型皮肤患者的安全性和有效性，而PIGMENT试验表明三联乳膏对V和VI型患者同样安全有效。

这一重要观察考虑到了黑斑病的深色皮肤的人群中特别常见。”

来自PIGMENT的总体资料显示，治疗前所有患者平均MASI得分为14.68,治疗4周后大约减少一半，为7.38，而至第8周，减少了75%，为3.64。进一步分析表明，治疗4周和8周后，在高加索人、非裔美国人/非裔黑人、亚洲人和西班牙人中得到相似的结果。各亚组MASI得分均下降，比基础值下降67%-78%。按Fitzpatrick皮肤分型分析表明，治疗前，深色皮肤类型者的平均MASI得分高（ I型11.5，VI型18.70）。

而治疗后，各组皮肤类型患者的平均MASI得分均明显下降，下降70%到85%不等。

研究者总体等级评定也证实了该药的疗效，治疗4周后，86%的患者开始改善。整个随访期间和治疗第8周，这一比例保持稳定，并有约30%患者黑斑消失或几乎消失。99%以上的不良反应为轻中度，皮肤刺激和红斑是最常见的副反应。

Torok也是上市前研究的研究者，他说：“令人鼓舞的是，这次研究显示三联乳膏的安全性比上市前试验的好，出现显效时间早 。

这次研究使用三联乳膏治疗的患者非常多，因此，PIGMENT试验可能提前得出有统计意义的治疗效果。III期试验确立了Tri-Luma乳膏治疗黑斑病的安全性和有效性。试验有641例I-IV型皮肤患者入组，其中161例使用三联乳膏治疗。

在这些研究中，约40%患者出现红斑和脱屑，而皮肤烧灼感、干燥和瘙痒的发生率分别为18%、14%和11%。

Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) is the only triple-action cream for the short-term and intermittent long-term treatment of moderate to severe melasma of the face.

Tri-Luma® Cream can help reduce or eliminate the discoloration caused by melasma. In fact, the combination of the three active ingredients in Tri-Luma® Cream is more effective than any combination of the individual components. Women treated with Tri-Luma® Cream also reported a favorable side effect profile as compared to women using various combinations of the ingredients.²

After using Tri-Luma® Cream for 8 weeks — women embarrassed to some degree by their melasma dropped from 82% of respondents to 40%.¹

Over the last week, how embarrassed or self-conscious have you been, because of your skin?¹ Response Baseline (%) Week 8 (%)  Very Much 19% 2%  A Lot 24% 5%  A Little 39% 33%  Not at All 18% 60%

Tri-Luma® Cream has been clinically proven — in three studies — to improve and frequently clear melasma after eight weeks of treatment. If melasma has not cleared in eight weeks, the latest long-term safety studies confirm that Tri-Luma® Cream is safe to use until melasma is resolved. It is also safe to use again whenever the condition reappears. Because melasma can be worsened by sun exposure, long-term therapy should include sun protection.

Women who are pregnant, plan to become pregnant or are nursing should wait to begin treatment with Tri-Luma® Cream until after pregnancy or when nursing has concluded. The safety and efficacy of Tri-Luma® Cream in pregnant women and nursing mothers have not been established.

1. Grimes P. Incidence and psychosocial implications of melasma. Presented at: American Academy of Dermatology; July 25-29, 2003; Chicago, Ill.
2. Data on file, Galderma Laboratories, L.P.

1. Grimes P. Incidence and psychosocial implications of melasma. Presented at: American Academy of Dermatology; July 25-29, 2003; Chicago, Ill.2. Data on file, Galderma Laboratories, L.P.

Tri-Luma® Cream is contraindicated in individuals with a hypersensitivity, allergy or intolerance to fluocinolone acetonide, hydroquinone or tretinoin. In clinical trials, the most frequently reported side effects were erythema, desquamation, burning, dryness and pruritus.

Mild to moderate redness, peeling, burning, dryness or itching may be experienced. This product contains sulfites that may cause severe allergic reactions including anaphylactic symptoms and life-threatening asthma attacks. Exposure to sunlight, sunlamps or UV light and extreme heat, wind or cold should be avoided. Use of sunscreen with appropriate SPF of 30 or higher is required. Wear protective clothing and change to nonhormonal forms of birth control, if hormonal methods are used.

Tri-Luma® Cream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, whose occurrence should prompt discontinuation of therapy. Tri-Luma® Cream contains the corticosteroid fluocinolone acetonide. Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment.