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一项针对患有轻至中度痤疮的青少年和成年人的单中心、开放标签研究,该研究采用一种含檀香油的专利0.5%水杨酸局部治疗方案。

Single-center, open-label study of a proprietary topical 0.5% salicylic acid-based treatment regimen containing sandalwood oil in adolescents and adults with mild to moderate acne.

作者信息

Moy Ronald L, Levenson Corey, So Jeffrey J, Rock James A

机构信息

Moy-Fincher Facial Plastics/Dermatology, Beverly Hills, CA, USA.

出版信息

J Drugs Dermatol. 2012 Dec;11(12):1403-8.

Abstract

BACKGROUND

A proprietary topical blend of salicylic acid and highly purified sandalwood oil from Australia was used in this open-label study in adolescents and adults with mild to moderate facial acne.

METHODS

The investigational regimen consisted of a foaming cleanser, an acne serum, a spot treatment, and a mask. Patients applied the treatment regimen as directed for 8 weeks. The primary efficacy measure was the percentage of patients assessed as improved, much improved, or very much improved according to the Global Aesthetic Improvement Scale (GAIS) ratings at week 8. Severity was rated using the Evaluator's Global Severity Scores (EGSS) at baseline and weeks 2, 4, and 8. Tolerability was assessed at baseline and weeks 2, 4, and 8 by asking patients to rate the severity of itching, scaling, erythema, burning, dryness, and stinging. Patients were also asked to complete an acne questionnaire.

RESULTS

89.4% (42/47) met the primary end point determined by the GAIS of improved (66%), much improved (19%), or very much improved (4%). Notable reductions in lesion counts were observed in patients with more severe or inflamed lesions. Tolerability was queried at all visits. No itching, scaling, or erythema was reported after initial application. Symptoms of intolerability peaked at week 2; however, most events were mild to moderate and were typically reported with use of the mask component. Intolerance decreased by week 4 and by week 8. The treatment regimen was well tolerated by patients.

CONCLUSIONS

Results from this study support the use of a proprietary investigational regimen in patients with mild to moderate acne and warrant further investigation to determine whether longer-term therapy (ie, beyond 8 weeks) results in enhanced efficacy with minimal side effects, leading to continued patient compliance and skin improvement.

摘要

背景

在这项针对轻度至中度面部痤疮的青少年和成人的开放标签研究中,使用了一种含有水杨酸和来自澳大利亚的高度纯化檀香油的专利局部混合制剂。

方法

研究方案包括一款泡沫洁面乳、一款痤疮血清、一款局部治疗剂和一款面膜。患者按指示使用该治疗方案,为期8周。主要疗效指标是根据第8周的全球美学改善量表(GAIS)评分被评估为改善、明显改善或非常明显改善的患者百分比。在基线以及第2、4和8周使用评估者全球严重程度评分(EGSS)对严重程度进行评级。通过让患者对瘙痒、脱屑、红斑、灼烧感、干燥和刺痛的严重程度进行评分,在基线以及第2、4和8周评估耐受性。还要求患者完成一份痤疮问卷。

结果

89.4%(42/47)达到了由GAIS确定的主要终点,即改善(66%)、明显改善(19%)或非常明显改善(4%)。在患有更严重或炎症性病变的患者中观察到病变数量显著减少。在所有访视中都对耐受性进行了询问。初次使用后未报告瘙痒、脱屑或红斑。不耐受症状在第2周达到峰值;然而,大多数事件为轻度至中度,通常在使用面膜成分时报告。到第4周和第8周时不耐受情况有所减轻。该治疗方案患者耐受性良好。

结论

本研究结果支持在轻度至中度痤疮患者中使用一种专利研究方案,并且有必要进一步研究以确定长期治疗(即超过8周)是否能在副作用最小的情况下提高疗效,从而使患者持续依从并改善皮肤状况。

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