15%壬二酸凝胶可治疗女性痤疮

土耳其伊斯坦布尔——根据一项对研究者设盲的为期9个月的随机临床试验结果，15%壬二酸凝胶可作为对成年女性痤疮患者有效和耐受性良好的治疗选择。德国马格德堡市Otto von Guericke大学的Thielitz医生在欧洲皮肤与性病学会(EADV)年会上报告了这项研究的结果。

这项单中心研究包含55例年龄18~45岁的女性，均患有轻至中度成人痤疮。患者被随机分为三组，分别接受以下3种治疗：15%壬二酸凝胶每日2次，治疗9个月；0.1%阿达帕林凝胶每日1次，治疗9个月；15%壬二酸凝胶每日2次，治疗3个月，之后单纯观察6个月。

结果显示，经3个月的治疗后，三组的炎症和非炎症痤疮病变计数、细微粉刺、痤疮评定量表评分、皮肤病生命质量指数评分改善相似。例如，中位总病变计数由约50降至20，中位Leeds改良痤疮评分系统评分由4降至大约2.5。维持活性治疗的两组在4~9个月期间的进一步改善程度相似。相反，在3个月后停用15%壬二酸凝胶的患者在无治疗的观察期内病情出现反复，但程度低于Thielitz医生的预期。9个月时，这组患者的总病变计数较9个月期间持续接受局部治疗的患者增加31%。此外，15%壬二酸凝胶的耐受性明显优于0.1%的阿达帕林凝胶。壬二酸治疗组的中位皮肤发红、干燥和剥落评分均显著低于阿达帕林治疗组。

值得注意的是，严格讲，15%壬二酸凝胶治疗女性成人痤疮是一种核准适应证之外的应用。这种药物的核准适应证为治疗轻至中度红斑痤疮。

研究者总结认为，对于成年女性痤疮患者，15%壬二酸凝胶的疗效与0.1%阿达帕林凝胶相似，且耐受性更优。

Thielitz博士披露，在这项由研究者发起的随机试验中无相关利益冲突。

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By: BRUCE JANCIN, Internal Medicine News Digital Network

ISTANBUL, TURKEY – Azelaic acid 15% gel constitutes an effective and well-tolerated treatment option for women with adult acne, according to the findings of an investigator-blinded, 9-month, randomized clinical trial.

The results showed azelaic acid 15% gel was similar in effectiveness to adapalene 0.1% gel, a widely prescribed treatment for this common condition, Dr. Anja Thielitz reported at the annual congress of the European Academy of Dermatology and Venereology.

However, azelaic acid 15% gel had a clear advantage in terms of tolerability. Median scores for skin redness, dryness, and scaling were significantly lower in the azelaic acid–treated group, added Dr. Thielitz of Otto von Guericke University in Magdeburg, Germany.

The single-center study involved 55 women aged 18-45 years, all with mild to moderate adult acne. They were randomized to one of three study arms: azelaic acid 15% gel twice daily for 9 months; adapalene 0.1% gel once daily, or 3 months of twice-daily azelaic acid 15% gel followed by 6 months of observation with no treatment.

Inflammatory and noninflammatory acne lesion counts, microcomedones, acne grading scale scores, and Dermatology Life Quality Index scores improved similarly in all three groups after 3 months. For example, median total lesion counts decreased from approximately 50 to 20, and median scores on the Leeds revised acne grading system dropped from 4 to roughly 2.5. Similar degrees of additional improvement were seen during months 4-9 in the two groups who remained on active treatment.

In contrast, some backsliding – although less than Dr. Thielitz had anticipated occurred during the untreated observation period among patients who halted the azelaic acid 15% gel after 3 months. By month 9, their total lesion count was 31% greater than the group that stayed on the topical therapy for the full 9 months.

Of note, azelaic acid 15% gel is technically an off-label therapy for adult female acne. The medication’s approved indication is in treating mild to moderate rosacea.

Dr. Thielitz reported having no financial conflicts in this investigator-initiated randomized trial.