Dosik Jonathan S, Arsonnaud Stephanie
TKL Research, Inc, Paramus, NJ, USA.
J Drugs Dermatol. 2007 Jun;6(6):632-8.
Topical retinoids, including adapalene and tazarotene, are a primary treatment choice for patients with acne. Adapalene is currently marketed in a 0.1% concentration in gel and cream formulation. A new gel containing a higher concentration (0.3%) of adapalene has been developed. In clinical studies, adapalene 0.1% concentration has proven to be better tolerated than other retinoids in skin treatment. However, the tolerability of adapalene gel 0.3% has yet to be compared to other topical retinoids.
The purpose of this study was to compare the local cutaneous tolerability of adapalene gel 0.3% once daily versus tazarotene cream 0.05% once daily.
Subjects reported to the investigative site each day Monday through Friday, cleansed the faced and then applied adapalene 0.3% gel to one side of the face and tazarotene 0.05% cream to the other in the presence of study personnel. For the weekends, subjects were instructed to apply the treatment at home according to the same procedure. Tolerability was assessed during each weekday visit. The study lasted for 3 weeks.
Tolerability results for adapalene 0.3% gel and tazarotene 0.05% cream were statistically similar throughout the study. Investigator-assessed overall tolerability was in favor of adapalene at days 19 and 22 (P=.043). A cosmetic acceptability survey also showed results were better for adapalene 0.3% gel.
Adapalene gel 0.3% is very well-tolerated with good cosmetic acceptability.
局部用维甲酸类药物,包括阿达帕林和他扎罗汀,是痤疮患者的主要治疗选择。阿达帕林目前以0.1%浓度的凝胶和乳膏剂型上市。一种含更高浓度(0.3%)阿达帕林的新型凝胶已被研发出来。在临床研究中,0.1%浓度的阿达帕林在皮肤治疗中已被证明比其他维甲酸类药物耐受性更好。然而,0.3%阿达帕林凝胶的耐受性尚未与其他局部用维甲酸类药物进行比较。
本研究的目的是比较每日一次外用0.3%阿达帕林凝胶与每日一次外用0.05%他扎罗汀乳膏的局部皮肤耐受性。
受试者周一至周五每天到研究地点报到,清洁面部,然后在研究人员在场的情况下,将0.3%阿达帕林凝胶涂于一侧面部,将0.05%他扎罗汀乳膏涂于另一侧面部。在周末,受试者被指示按照相同程序在家中进行治疗。在每个工作日的访视中评估耐受性。研究持续3周。
在整个研究过程中,0.3%阿达帕林凝胶和0.05%他扎罗汀乳膏的耐受性结果在统计学上相似。研究人员评估的总体耐受性在第19天和第22天有利于阿达帕林(P = 0.043)。一项化妆品可接受性调查也显示0.3%阿达帕林凝胶的结果更好。
0.3%阿达帕林凝胶耐受性良好,具有良好的化妆品可接受性。