近日，美国食品和药物管理局（FDA）批准Altreno（tretinoin，维甲酸乳液 0.05%）用于9岁及以上患者寻常痤疮的局部治疗。Altreno是首个乳液配方的维甲酸产品。
用药方面:Altreno每日一次局部涂抹，当日光照射不能避免时，患者应穿戴防晒工具和防护服。
批准日期：2018年8月23日 公司：Ortho公司
ALTRENO（维甲酸 tretinoin）乳液 0.05%，局部使用
最初的美国批准：1973年
作用机制
维甲酸是维生素A的代谢产物，其与细胞质和细胞质中的特定视黄酸受体具有高亲和力结合。
核。
维甲酸激活视黄酸（RAR）核受体（RARα，RARβ和RARγ）的三个成员，其作用是修饰基因
表达，随后的蛋白质合成和上皮细胞生长和分化。尚未确定是否临床维甲酸的作用是通过激活视黄酸受体，其他机制或两者来介导的。
尽管维生素A在痤疮治疗中的确切作用方式尚不清楚，但目前的证据表明局部维生素A酸降低
卵泡上皮细胞的粘连性与微小的形成减少。另外，维甲酸刺激有丝分裂活性并且增加了滤泡上皮细胞的周转，导致粉刺的挤压。
适应症和用法
ALTRENO是一种维甲酸，适用于9岁及以上患者的寻常痤疮局部治疗。
剂量和给药
•每天一次在受影响的区域涂上一层薄薄的ALTRENO。避免眼睛，嘴巴，鼻旁褶皱和粘膜。
•不适用于眼科，口腔或阴道内使用。
剂量形式和强度
乳液，0.05％
每克ALTRENO含有0.5mg（0.05％）维生素A酸。
禁忌症
没有。
警告和注意事项
•皮肤刺激：使用ALTRENO可能导致干燥，疼痛，红斑，刺激和去角质。
•紫外线和环境暴露：最大限度地减少曝光和太阳光。无法避免日晒时使用防晒霜和防护服。
•鱼过敏：如果过敏对鱼有过敏反应，请使用ALTRENO对鱼蛋白的过敏性。如果患者出现瘙痒或荨麻疹，建议患者联系他们的医疗保健提供者。
不良反应
•≥1％的受试者中发生的最常见的不良反应是干燥，疼痛，红斑，刺激和皮肤松弛（均在应用部位）。
如何提供/存储和处理
ALTRENO（维甲酸）乳液，0.05％是一种不透明的淡黄色外用乳液，可用作：
•45克管（NDC 0187-0005-45）
储存和处理条件
储存在20°至25°C（68°至77°F）; 允许偏移15°至30°C（59°至86°F）[见USP受控室温]。
防止冻结。

完整说明资料附件：https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209353s000lbl.pdf
Retinoic acid emulsion Altreno is approved by the FDA for acne vulgaris
Recently, Ortho announced that the US Food and Drug Administration (FDA) has approved Altreno (tretinoin, retinoic acid, 0.05%) emulsion for topical treatment of acne vulgaris in patients 9 years of age and older. Altreno is the first emulsion formulation for retinoids.
In terms of medication, Altreno is applied once a day. When sun exposure is unavoidable, patients should wear sun protection tools and protective clothing. Altreno should be used with caution if the patient is allergic to fish.
Altreno's approval is based on data from a Phase III clinical project. The project included two identical multicenter, randomized, double-blind, vehicle-controlled phase III studies enrolling 1,640 patients with moderate to severe acne vulgaris aged 9 years and older to assess the efficacy and safety of the drug. . Common primary endpoints of the study included: acne overall severity score (EGSS) success rate at 12 weeks of treatment (defined as: ≥ 2 improvement from baseline and EGSS scores were clear or nearly clear), non-inflammatory lesions, and inflammatory lesion counts Absolute change.
The results of the study showed that the Altreno emulsion significantly improved the success rate of EGSS, significantly reduced inflammatory and non-inflammatory facial lesions, significantly improved patient satisfaction, and was generally well tolerated compared to vehicle. The specific data is:
(1) The first and second studies showed that at the 12th week of treatment, a higher proportion of patients in the Altreno treatment group achieved success in EGSS compared with the vehicle group, 16.5% vs 6.9%, respectively. 19.8% vs 12.5%; the mean reduction in non-inflammatory facial lesions was 47.5% (27.3% in the vehicle group), and 45.% (31.9% in the vehicle group); the average reduction in inflammatory facial lesions was 50.9% ( The vehicle group was 40.4%) and 53.4% ​​(41.5% in the vehicle group).
(2) The data also showed that at the 12th week of treatment, the satisfaction of patients in the Altreno treatment group (based on 1396 surveys completed at the 12th week of treatment) was significantly improved compared with the vehicle group: treatment group satisfaction increased by 53% The vehicle group was increased by 43% (p < 0.001). 90% of patients reported satisfaction with Altreno treatment.
(3) There was a statistically significant increase in the mean acne-quality of life (Acne-QoL) assessment in the Altreno treatment group compared with the vehicle group: mean score versus baseline change: self-perception (7.4 vs 6.7, p= 0.003), role-emotion (7.4 vs 6.7, p=0.003), social role (4.8 vs 4.6, p=0.038), acne symptoms (6.5 vs 5.6, p<0.001).
(4) In terms of safety, the incidence of Altreno treatment group >1% and higher than the most common adverse reactions in the vehicle group included: dry skin, painful erythema, irritation and shedding.
 Acne, commonly known as acne and acne, is one of the most common chronic skin diseases in the world. In the United States alone, about 50 million patients suffer from it. Acne is an infectious inflammation of the hair follicle sebaceous glands, which occurs mostly in adolescence and has a great psychological and social impact on adolescents, but it is often naturally relieved or healed after puberty. Clinically, hemorrhoids are characterized by pleomorphic skin lesions such as acne, papules, pustules, and nodules that occur on the face, but can also occur in the chest, upper back, and shoulders. According to the severity, acne may cause emotional distress and skin scarring.
A large number of clinical data indicate that retinoids are very effective in the treatment of acne and are considered to be the cornerstone of topical treatments for acne. However, a common sensory disorder associated with retinoid medications is skin irritation such as dryness, peeling, and skin sensitivity. In clinical studies, Altreno Emulsion has demonstrated the proven efficacy of retinoic acid and is generally well tolerated, with dry skin, pain, swelling, irritation and exfoliation reported in ≤4% of patients.
Ortho's president, Bill Humphries, said Altreno's FDA approval will further expand the company's acne portfolio, which will provide doctors and patients with a reliable retinoic acid emulsion formulation that includes hyaluronic acid, glycerin and collagen. Such as moisturizers, will effectively improve the patient's experience. Altreno Emulsion is easy to use and quickly absorbed by the skin, making it easy for acne patients to incorporate this once-a-day topical treatment into their daily skin care regimen.