Sandoval Laura F, Semble Ashley, Gustafson Cheryl J, Huang Karen E, Levender Michelle M, Feldman Steven R
J Drugs Dermatol. 2014 Feb;13(2):135-40.
The treatment of acne can be difficult, with suboptimal adherence resulting in poor treatment outcomes.
To determine whether demonstrating to patients how to properly apply a topical acne medication through the use of a sample product will improve adherence.
Subjects with mild to moderate acne were instructed to use adapalene/benzoyl peroxide gel once daily for six weeks. Subjects were randomized into sample or no sample group. Sample group received a demonstration on how to apply the medication using a product sample. The primary outcome was median adherence, recorded using electronic monitoring, and secondary outcomes were efficacy measures including the Acne Global Assessment (AGA) and lesion counts and the Perceived Medical Condition Self-Management Scale (PMCSMS).
Data from 17 patients was collected and analyzed. Median adherence rates were 50% in the sample group and 35% in the no sample group (p=0.67). The median percent improvement in non-inflammatory lesions were 46% for the sample group and 33% for the no-sample group (p=0.10).
The small size of this pilot study limited the extent of subgroup analyses.
Objective electronic monitoring expanded our previous observations of poor adherence in the treatment of acne. There is a considerable potential effect size on adherence for the use of samples, supporting the need for future, well powered studies to assess the value of using samples in the treatment of acne and other dermatologic skin diseases.
痤疮的治疗可能具有挑战性,依从性欠佳会导致治疗效果不佳。
确定通过使用样品向患者演示如何正确涂抹外用痤疮药物是否会提高依从性。
轻度至中度痤疮患者被指示每天使用一次阿达帕林/过氧化苯甲酰凝胶,持续六周。受试者被随机分为样品组或无样品组。样品组接受了使用产品样品涂抹药物的演示。主要结局是使用电子监测记录的中位依从性,次要结局是疗效指标,包括痤疮整体评估(AGA)、皮损计数和自我感知医疗状况管理量表(PMCSMS)。
收集并分析了17例患者的数据。样品组的中位依从率为50%,无样品组为35%(p=0.67)。样品组非炎性皮损改善的中位百分比为46%,无样品组为33%(p=0.10)。
这项初步研究的样本量较小,限制了亚组分析的范围。
客观的电子监测扩展了我们之前对痤疮治疗中依从性差的观察结果。使用样品对依从性有相当大的潜在效应量,这支持未来需要进行有充分统计学效力的研究,以评估在痤疮和其他皮肤疾病治疗中使用样品的价值。