Traikovich S S
Beeson Aesthetic Surgery Institute, Carmel, Ind., USA.
Arch Otolaryngol Head Neck Surg. 1999 Oct;125(10):1091-8. doi: 10.1001/archotol.125.10.1091.
To determine the efficacy of topical ascorbic acid application in treating mild to moderate photodamage of facial skin using an objective, computer-assisted image analysis of skin surface topography and subjective clinical, photographic, and patient self-appraisal questionnaires.
A 3-month, randomized, double-blind, vehicle-controlled study.
Facial plastic surgery private practice.
Nineteen evaluable volunteer sample patients aged between 36 and 72 years with Fitzpatrick skin types I, II, and III who were in good physical and mental health with mild to moderately photodamaged facial skin were considered for analysis.
Coded, unmarked medications were randomly assigned to the left and right sides of each subject's face, one containing the active agent, topical ascorbic acid (Cellex-C high-potency serum; Cellex-C International, Toronto, Ontario), the other, the vehicle serum (Cellex-C International). Three drops (0.5 mL) of each formulation were applied daily to the randomly assigned hemifaces over the 3-month study period. Treatment assignments were not disclosed to subjects, clinicians, or personnel involved in analyzing skin replicas.
Specific clinical parameters were evaluated and graded on a 0- to 9-point scale (0, none; 1-3, mild; 4-6, moderate; and 7-9, severe). Reference photographs were used to standardize grading criteria. Overall investigator scores were compared with baseline and graded as excellent (much improved), good (improved), fair (slightly improved), no change, or worse. Patient self-appraisal questionnaires rated the degree of improvement (much improved, improved, slightly improved, no change, or worse) and reported adverse effects (burning, stinging, redness, peeling, dryness, discoloration, itching, and rash). Standard photographs were taken at baseline, including anteroposterior and left and right oblique views to facilitate subsequent clinical evaluations, and at the end of therapy for comparison. Optical profilometry analysis was performed on the skin surface replicas of the lateral canthal (crow's feet) region, comparing baseline to end-of-study specimens. Using this computer-based system, the resulting image was digitally analyzed, and numeric values were assigned to reflect surface features. The parameters obtained included Rz, Ra, and shadows. These values provided objective data that document pretreatment and posttreatment texture changes proportional to the degree of wrinkling, roughness, and other surface irregularities.
Optical profilometry image analysis demonstrated a statistically significant 73.7% improvement in the Ra and shadows north-south facial axis values with active treatment greater than vehicle control, as well as a trend for improvement in the Rz north-south facial axis parameter, showing a 68.4% greater improvement of active treatment vs vehicle control. Clinical assessment demonstrated significant improvement with active treatment greater than control for fine wrinkling, tactile roughness, coarse rhytids, skin laxity/tone, sallowness/yellowing, and overall features. Patient questionnaire results demonstrated statistically significant improvement overall, active treatment 84.2% greater than control. Photographic assessment demonstrated significant improvement, active treatment 57.9% greater than control.
A 3-month daily regimen of topical ascorbic acid provided objective and subjective improvement in photodamaged facial skin. Skin replica optical profilometry is an objective method for quantification of the skin surface texture changes.
采用客观的计算机辅助皮肤表面形貌图像分析以及主观的临床、摄影和患者自我评估问卷,确定外用抗坏血酸治疗面部皮肤轻至中度光损伤的疗效。
一项为期3个月的随机、双盲、赋形剂对照研究。
面部整形手术私人诊所。
19名可评估的志愿者样本患者,年龄在36至72岁之间,皮肤类型为Fitzpatrick I、II和III型,身心健康,面部皮肤有轻至中度光损伤,纳入分析。
将编码且无标记的药物随机分配至每个受试者面部的左侧和右侧,一种含有活性剂外用抗坏血酸(Cellex-C高效血清;Cellex-C International,多伦多,安大略省),另一种为赋形剂血清(Cellex-C International)。在为期3个月的研究期间,每天将每种制剂的三滴(0.5 mL)涂抹于随机分配的半侧面部。治疗分配情况未向受试者、临床医生或参与分析皮肤复制品的人员透露。
特定临床参数采用0至9分制进行评估和分级(0分表示无;1 - 3分为轻度;4 - 6分为中度;7 - 9分为重度)。使用参考照片标准化分级标准。将研究者的总体评分与基线进行比较,并分为优(改善明显)、良(改善)、中(略有改善)、无变化或差。患者自我评估问卷对改善程度(改善明显、改善、略有改善、无变化或差)进行评分,并报告不良反应(灼烧感、刺痛感、发红、脱皮、干燥、变色、瘙痒和皮疹)。在基线时拍摄标准照片,包括前后位以及左右斜位照片,以便于后续临床评估,并在治疗结束时拍摄照片进行比较。对内外眦(鱼尾纹)区域的皮肤表面复制品进行光学轮廓分析,将基线标本与研究结束时的标本进行比较。使用该基于计算机的系统,对所得图像进行数字分析,并赋予数值以反映表面特征。获得的参数包括Rz、Ra和阴影。这些值提供了客观数据,记录了与皱纹程度、粗糙度和其他表面不规则性成比例的治疗前和治疗后质地变化。
光学轮廓图像分析显示,活性治疗组的Ra和阴影南北面部轴值在统计学上有显著改善,改善率为73.7%,高于赋形剂对照组,并且Rz南北面部轴参数有改善趋势,活性治疗组比赋形剂对照组的改善率高68.4%。临床评估表明,活性治疗组在细纹、触觉粗糙度、粗大皱纹、皮肤松弛度/色泽、面色发黄/泛黄以及整体特征方面比对照组有显著改善。患者问卷结果总体上显示有统计学意义的改善,活性治疗组比对照组高84.2%。摄影评估显示有显著改善,活性治疗组比对照组高57.9%。
为期3个月的每日外用抗坏血酸方案对面部光损伤皮肤有客观和主观的改善。皮肤复制品光学轮廓分析是一种量化皮肤表面质地变化的客观方法。