阿达帕林凝胶治疗光化性角化病和雀斑样痣的评估：一项随机试验。

Assessment of adapalene gel for the treatment of actinic keratoses and lentigines: a randomized trial.

作者信息

Kang Sewon, Goldfarb Michael T, Weiss Jonathan S, Metz Russell D, Hamilton Ted A, Voorhees John J, Griffiths Christopher E M

机构信息

University of Michigan School of Medicine, Department of Dermatology, Ann Arbor, USA.

出版信息

J Am Acad Dermatol. 2003 Jul;49(1):83-90. doi: 10.1067/mjd.2003.451.

DOI:10.1067/mjd.2003.451

PMID:12833014

Abstract

BACKGROUND

Adapalene is a synthetic retinoid with an established clinical efficacy against acne and good local tolerability. Its effectiveness in the treatment of photodamaged skin has not been studied.

OBJECTIVE

We sought to determine the safety and efficacy of adapalene gel in the treatment of actinic keratoses and solar lentigines.

METHODS

In a prospective, 2-center, randomized, controlled, investigator-masked, parallel-group study, 90 patients with actinic keratoses and solar lentigines were treated daily with either adapalene gel (0.1% or 0.3%) or its vehicle gel for 4 weeks, followed by twice-daily applications, if tolerated, for up to 9 months.

RESULTS

Of the 90 Caucasian patients (69 male, 21 female; mean age 63.1 years) who were enrolled into the study, 83 patients completed 9 months of treatment. With adapalene gel 0.1% and 0.3%, the mean number of actinic keratoses was reduced by 0.5 +/- 0.9 (mean +/- SE) and 2.5 +/- 0.9, respectively. Whereas, with the vehicle gel, there was an increase of 1.5 +/- 1.3 (P <.05). After 1 month of treatment, the patients who received adapalene had significant lightening of solar lentigines as compared with the patients who were treated with vehicle gel (P <.05). After 9 months, 57% and 59% of the patients had lighter lesions in the adapalene 0.1% and 0.3% groups, respectively, in comparison with only 36% in the vehicle group (P <.05). Histologic evaluations revealed improved cellular atypia and reduced epidermal melanin in adapalene-, as compared with vehicle-treated group. The differences, however, were not statistically significant. A retrospective evaluation of paired clinical photographs (before and after 9-month treatment) by 2 dermatologists who were treatment-blinded revealed significant improvement in wrinkles and other clinical features of photoaged skin with adapalene as compared with its vehicle.

CONCLUSION

Adapalene gel 0.1% and 0.3% were well tolerated and improved actinic keratoses, solar lentigines, and other features of photodamaged skin.

摘要

背景

阿达帕林是一种合成类视黄醇，对痤疮具有确切的临床疗效且局部耐受性良好。其在治疗光损伤皮肤方面的有效性尚未得到研究。

目的

我们旨在确定阿达帕林凝胶治疗光化性角化病和日光性雀斑样痣的安全性和有效性。

方法

在一项前瞻性、双中心、随机、对照、研究者设盲、平行组研究中，90例光化性角化病和日光性雀斑样痣患者每天分别使用阿达帕林凝胶（0.1%或0.3%）或其基质凝胶治疗4周，若耐受则随后每日两次应用，最长可达9个月。

结果

纳入研究的90例白种人患者（69例男性，21例女性；平均年龄63.1岁）中，83例患者完成了9个月的治疗。使用0.1%和0.3%阿达帕林凝胶时，光化性角化病的平均数量分别减少了0.5±0.9（均值±标准误）和2.5±0.9，而使用基质凝胶时数量增加了1.5±1.3（P<.05）。治疗1个月后，与使用基质凝胶治疗的患者相比，接受阿达帕林治疗的患者日光性雀斑样痣明显变浅（P<.05）。9个月后，0.1%和0.3%阿达帕林凝胶组分别有57%和59%的患者皮损变浅，而基质凝胶组仅为36%（P<.05）。组织学评估显示，与基质凝胶治疗组相比，阿达帕林治疗组细胞异型性改善，表皮黑色素减少。然而，差异无统计学意义。两位对治疗不知情的皮肤科医生对9个月治疗前后的配对临床照片进行回顾性评估发现，与基质凝胶相比，阿达帕林可使光老化皮肤的皱纹和其他临床特征有显著改善。