Sendagorta E, Lesiewicz J, Armstrong R B
Department of Clinical Research (Dermatology), Roche International Clinical Research Center, Nutley, N.J.
J Am Acad Dermatol. 1992 Dec;27(6 Pt 2):S15-8. doi: 10.1016/s0190-9622(08)80254-x.
Photodamaged skin is characterized clinically by coarseness, telangiectasia, wrinkling, discrete hyperpigmented and hypopigmented macules, atrophy, and ultimately the development of neoplasms. Studies on the UVB-irradiated hairless mouse indicate that topical application of tretinoin or isotretinoin induces structural modifications at the dermal level. Clinical trials indicate that tretinoin improves skin appearance in patients who have photodamage. This double-blind, vehicle-controlled clinical trial was conducted to determine whether 36 weeks of treatment with topical isotretinoin improves mildly to moderately photodamaged facial skin. After they gave written informed consent 776 patients were randomly assigned to 36 weeks of treatment with either vehicle cream or isotretinoin cream, applied once nightly. Efficacy was evaluated by means of physician and patient assessment and a blinded analysis of standardized photographs taken before and after treatment. When compared with vehicle, treatment with isotretinoin resulted in statistically significant improvement in overall appearance, fine wrinkling, discrete pigmentation, sallowness, and texture. Isotretinoin cream was well tolerated.
光损伤皮肤的临床特征为粗糙、毛细血管扩张、皱纹、散在的色素沉着和色素减退斑、萎缩,最终发展为肿瘤。对紫外线B照射的无毛小鼠的研究表明,局部应用维甲酸或异维甲酸可在真皮水平诱导结构改变。临床试验表明,维甲酸可改善光损伤患者的皮肤外观。进行这项双盲、赋形剂对照临床试验是为了确定局部应用异维甲酸治疗36周是否能改善轻度至中度光损伤的面部皮肤。在776例患者签署书面知情同意书后,将其随机分为两组,分别接受赋形剂乳膏或异维甲酸乳膏治疗,每晚涂抹一次,持续36周。通过医生和患者评估以及对治疗前后拍摄的标准化照片进行盲法分析来评估疗效。与赋形剂相比,异维甲酸治疗在整体外观、细纹、散在色素沉着、皮肤发黄和质地方面有统计学意义的显著改善。异维甲酸乳膏耐受性良好。