■衰老是生命的自然过程。随着年龄的增长,皮肤遭受进行性形态和生理衰退。色素沉着过度,皱纹,皮肤粗糙是老化皮肤的一些症状。暴露在阳光下,污染,压力,尼古丁,等会加剧皮肤老化。这项研究旨在确定多草药制剂的疗效和安全性,并将其与标准药物维甲酸在中度至晚期光老化面部皮肤受试者中的疗效进行比较。多草药配方的成分是Aaradebaqla(蚕豆),Jau(Hordeumvulgare),Nakhud(Cicerarietinum),Masoor(透镜esculenta),Tukhmeturb(Raphanussativus),Khardal(Brassicanigra),Haldi(姜黄),Kateera(Cochlospermumreligiosum)。
■这是一项随机开放标签标准对照研究。通过计算机生成的随机数将82名合格的受试者平均分配到测试组和对照组中。在测试组中,牛奶中的15gm多草药配方的糊状物,和对照组,0.025%维甲酸1克局部用于面部,每天一次,持续两个月。临床医师使用以下不同参数的不同量表评估反应。
■通过皮肤色素沉着指数在线计算器(SHI)对其进行评估。它描述了两个分数的比例,即受影响区域的色素沉着过度的皮肤和同一患者的正常防晒皮肤。用数字显微镜-Win7从色素沉着过度区域和正常防晒区域记录图像。这两个图像都在https://shi上上传。skinimageanalysis.com/并计算了色素沉着过度的平均值。SHI的范围从1(无色素沉着过度)到4(最大色素沉着过度),其中1和2之间的分数显示为轻度色素沉着,2-3为中度色素沉着,评分在3到4之间为严重的色素沉着。
通过数字摄影测定细皱纹数。照片是通过佳能EOS1500DDSLR相机拍摄的,镜头为18-55毫米。每个受试者的脸都拍摄了三张照片(右,左,和中心全脸)在基线和第15天,30日,45岁,和第60次评估其细皱纹评分的可见变化/改善。
■改良的Fitzpatrick皱纹量表(MFWS)用于评估鼻唇沟。量表包括四个主要类别的鼻唇皱纹:0,1,2和3代表缺失,好,中度,和深深的皱纹,分别,和三个类间,即,0.5、1.5和2.5来估计皱纹深度。标度的全部类别的定义如下:类别0=无皱纹。没有可见的皱纹;连续的皮肤线;0.5级=非常浅但可见的皱纹;1级=细皱纹。可见的皱纹和轻微的压痕;等级1.5=可见的皱纹和清晰的压痕。<1mm皱纹深度;2级=中度皱纹。可见的皱纹,1至2毫米的皱纹深度;2.5级=突出和可见的皱纹。大于2mm且小于3mm的起皱深度;3类=深起皱。深沟皱纹;皱纹深度超过3毫米。
■通过经验证的额头线分级量表评估额头线(数量和深度)。额头线等级量表是5点光子数字等级量表,旨在客观地量化静息(静态)和多动(动态)的额头线。没有皱纹的等级为0,1在休息时没有皱纹,但面部表情细纹,2用于静止时出现的细纹和面部表情的深层皱纹,3适用于休息时出现的细纹和面部表情较深的线条,和4,用于休息时更深的皱纹和面部表情更深的皱纹。
■通过经验证的乌鸦脚分级量表确定横向can线的数量。乌鸦脚等级量表是一种5点光子数字等级量表,用于客观量化乌鸦脚的严重程度。该量表适用于乌鸦脚的两个单独评估:静止(静态)和表情(动态)。没有皱纹的等级为0,1用于非常细的皱纹,2适用于细纹,3用于中度皱纹,和4严重的皱纹。
Allergan皮肤粗糙度量表用于面部皮肤粗糙度评估。Allergan皮肤粗糙度量表的评估区域是鼻唇沟到耳前脸颊之间的区域,从眶下缘到下颌骨。Allergan皮肤粗糙度量表从无(0)到极端(4)的等级描述了皮肤粗糙度的严重程度,交叉阴影线,和面部中部的弹性沉着症。尺度分级为0(无)平滑视觉皮肤纹理,1(最小)稍微粗糙和不均匀的视觉皮肤纹理,2(中度)中度粗糙和不均匀的视觉皮肤纹理;可能有早期弹性沉着症,3(严重)严重粗糙的视觉皮肤纹理,交叉阴影细线;可能有一些弹性增生,和4(极端)极其粗糙的视觉皮肤纹理,交叉阴影深折痕;极度弹性沉着症。
■在临床基础上评估谷度,任意评分范围从0到9,其中0-3=轻度,3.5-6=中度,6.5-9=严重的面部皮肤暗沉。
■通过皮肤病学生活质量指数问卷评估受试者的生活质量。它包括10个问题。每个问题都以四点李克特量表进行评分:非常=3,很多=2,一点点=1,根本不=0,不相关=0,未回答问题=0。DLQI是通过将每个问题的分数相加来计算的,导致最大值为30,最小值为0。Where,0-1=对患者的生活完全没有影响,2-5=对患者生活影响小,6-10=对患者生活的中度影响,11-20=对病人的生活有很大的影响,21-30=对患者生命的极大影响。
■两组患者的皱纹均有显著改善,额头线条,乌鸦的脚,粗糙度,矮化,鼻唇折叠,色素沉着过度,和生活质量参数。(P<.001)对照组中有大量受试者报告轻度至中度发红,瘙痒,干燥度,皮肤变黑,在测试组中,治疗期间绝对没有副作用的报道.
■两组的效果都很大,但多草药配方是安全和有效的用于光老化面部皮肤。它可能是更可行的容易获得的廉价和安全的配方,以防止皮肤老化和恢复皮肤弹性并使皮肤更亮。应进行进一步的研究,以使用标准仪器评估配方对客观参数的功效,以进行适当的参数测量。
UNASSIGNED: Ageing is a natural process of life. With increasing age, the skin suffers progressive morphological and physiological decrement. Hyperpigmentation, Wrinkles, and roughness of skin are some of the symptoms of aged skin. Exposure to sunlight, pollution, stress, nicotine, etc aggravates Skin aging. This study aimed to determine the efficacy and safety of polyherbal formulation and compare its efficacy with the standard drug tretinoin in subjects of moderate to advanced Photoaged facial skin. Ingredients of polyherbal formulation are Aarade baqla (Vicia faba), Jau (Hordeum vulgare), Nakhud (Cicer arietinum),Masoor (Lens esculenta), Tukhm e turb (Raphanus sativus), Khardal (Brassica nigra), Haldi (Curcuma longa), Kateera (Cochlospermum religiosum).
UNASSIGNED: This was a randomized open-label standard controlled study. 82 eligible subjects were allocated equally into test and control groups by computer-generated random numbers. In the test group, a paste of 15 gm polyherbal formulation in milk, and the control group, 0.025% Tretinoin 1 gram was used topically on the face once a day for two months. The response was assessed by theclinician using following different scales for different parameters.
UNASSIGNED: It was assessed by the Skin Hyperpigmentation Index online calculator (SHI). It describes the ratio of two scores, namely the hyperpigmented skin of the affected area and normal sun-protected skin from the same patient. The image was recorded with a Digital microscope-Win7 from a hyperpigmented area and normal sun-protected area. Both the images were uploaded on https://shi.skinimageanalysis.com/ and calculated the mean value of hyperpigmentation. SHI ranges from 1 (no hyperpigmentation) to 4 (maximum hyperpigmentation) where scores between 1 and 2 showed as light hyperpigmentation, 2-3 as medium hyperpigmentation, and scores between 3 and 4 as severe hyperpigmentation.
UNASSIGNED: Fine wrinkles number was determined by digital photography. The photographs were taken through Canon EOS 1500D DSLR Camera with an 18-55 mm Lens. Three images were taken of each subject\'s face (right, left, and center full face) on Baseline and Day 15th, 30th, 45th, and 60th to assess visible changes/improvement in their fine wrinkles score.
UNASSIGNED: Modified Fitzpatrick Wrinkle Scale (MFWS) was used to assess Nasolabial folds. The scale comprised four main classes of Nasolabial wrinkling: 0, 1, 2, and 3 representing absent, fine, moderate, and deep wrinkles, respectively, and three inter classes i.e., 0.5, 1.5, and 2.5 to estimate wrinkle depth. The definitions of the entire classes of the scale are as follows: Class 0 = No wrinkle. No visible wrinkle; continuous skin line; Class 0.5 = Very shallow yet visible wrinkle; Class 1= Fine wrinkle. Visible wrinkle and slight indentation; Class 1.5= Visible wrinkle and clear indentation. <1-mm wrinkle depth; Class 2= Moderate wrinkle. Visible wrinkle, 1- to 2-mm wrinkle depth; Class 2.5= Prominent and visible wrinkle. More than 2-mm and less than 3-mm wrinkle depth; Class 3=Deep wrinkle. Deep and furrow wrinkle; more than 3-mm wrinkle depth.
UNASSIGNED: Forehead lines were assessed (number and depth) by a Validated Grading Scale for Forehead Lines. The Forehead Lines Grading Scale is a 5- point photonumeric rating scale that was developed to objectively quantify resting (static) and hyperkinetic (dynamic) forehead lines. The scale ratings are 0 for no wrinkles, 1 for no wrinkles present at rest but fine lines with facial expression, 2 for fine wrinkles present at rest and deep lines with facial expression, 3 for fine wrinkles present at rest and deeper lines with facial expression, and 4 for deeper wrinkles at rest and deeper furrows with facial expression.
UNASSIGNED: The number of lateral canthal lines was determined by a Validated Grading Scale for Crow\'s Feet. The Crow\'s Feet Grading Scale is a 5- point photonumeric rating scale developed to objectively quantify the severity of crow\'s feet. This scale was applied to two separate evaluations of crow\'s feet: at rest (static) and with expression (dynamic). The scale ratings are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.
UNASSIGNED: The Allergan Skin Roughness Scale was used for facial skin roughness assessment. The area of assessment for the Allergan Skin roughness Scale is the area between the nasolabial fold to the preauricular cheek and from the inferior orbital rim to the mandible. The Allergan Skin Roughness Scale assigns a grade from none (0) to extreme (4) that describes the severity of skin coarseness, crosshatching, and elastosis in the midface area. The scale grading are 0 (None) Smooth visual skin texture, 1 (Minimal) Slightly coarse and uneven visual skin texture, 2 (Moderate) Moderately coarse and uneven visual skin texture; may have early elastosis, 3 (Severe) Severely coarse visual skin texture, cross-hatched fine lines; may have some elastosis, and 4 (Extreme) Extremely coarse visual skin texture, cross Hatched deep creases; extreme elastosis.
UNASSIGNED: Dullness was assessed on a clinical basis with an arbitrary scoring ranging from 0 to 9 where 0-3=mild, 3.5-6=moderate, and 6.5-9=severe facial skin dullness.
UNASSIGNED: Subjects\' life quality was assessed by the Dermatology Life Quality Index questionnaire. It consists of 10 questions. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0 and Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. Where, 0-1= no effect at all on patient\'s life, 2-5 = small effect on patient\'s life, 6-10 = moderate effect on patient\'s life, 11-20 = very large effect on patient\'s life, 21-30 = extremely large effect on patient\'s life.
UNASSIGNED: Both groups showed a significant improvement in Fine Wrinkles, Forehead Lines, Crow\'s Feet, Roughness, Dullness, Nasolabial Fold, Hyperpigmentation, and Quality of Life parameters. (P < .001) A large number of subjects in the control group reported mild to moderate redness, itching, dryness, and blackening of the skin, while in the test group, absolutely no side effects were reported during treatment.
UNASSIGNED: The effects in both groups were substantial, but the polyherbal formulation is safe and effective for use in photoaged facial skin. It may be a more feasible easily accessible cheap and safe formulation to prevent skin aging and restore skin elasticity and make skin brighter. Further studies to evaluate the efficacy of formulation on objective parameters using standard instruments should be done for appropriate measurements of parameters.