Carmo Egberto Santos, Pereira Fillipe de Oliveira, Cavalcante Neuza Maria, Gayoso Carla Wanderley, Lima Edeltrudes de Oliveira
Federal University of Campina Grande (UFCG) - Cuité (PB), Brazil.
An Bras Dermatol. 2013 May-Jun;88(3):381-5. doi: 10.1590/abd1806-4841.20131800.
Pityriasis versicolor is a fungal infection caused by Malassezia spp. that has frequent relapses.
The main objective of this research was to perform phase I and II clinical studies, using formulations containing essential oil of Cymbopogon citratus in patients with pityriasis versicolor.
Phase I study included twenty volunteers to ascertain the safety of the formulations. In phase II, 47 volunteers randomly received essential oil formulations at 1.25 μL/mL concentration, for forty days. The shampoo should be applied three times a week and the cream twice a day. A control group in phase II, consisting of 29 volunteers, received the same formulations but with 2% ketoconazole as the active ingredient.
No significant adverse events were observed in volunteers during Phase I. In Phase II, 30 (63.83%) volunteers using essential oil and 18 (62.07%) using ketoconazole remained until the end of the study. We observed a predominance of lesions in disseminated form, with M. sympodialis detected as the predominant agent identified in cultures. After 40 days of treatment, the rate of mycological cure was 60% (p <0.05) for the group treated with essential oil of C. citratus and over 80% (p <0.05) for the group treated with ketoconazole formulations.
Notwithstanding the safety and antifungal effects observed in this study after application of formulations containing the essential oil of C. citratus, further studies with larger populations should be performed to confirm the actual potential of these formulations in the treatment of patients with Pityriasis versicolor.
花斑糠疹是由马拉色菌属引起的真菌感染,易频繁复发。
本研究的主要目的是对花斑糠疹患者进行含柠檬香茅精油制剂的Ⅰ期和Ⅱ期临床研究。
Ⅰ期研究纳入20名志愿者以确定制剂的安全性。在Ⅱ期,47名志愿者随机接受浓度为1.25μL/mL的精油制剂,持续40天。洗发水应每周使用3次,乳膏每天使用2次。Ⅱ期的一个由29名志愿者组成的对照组接受相同制剂,但活性成分是2%的酮康唑。
Ⅰ期志愿者未观察到明显不良事件。在Ⅱ期,使用精油的30名(63.83%)志愿者和使用酮康唑的18名(62.07%)志愿者完成了研究。我们观察到以播散型损害为主,培养中检测到合轴马拉色菌为主要病原体。治疗40天后,柠檬香茅精油治疗组的真菌学治愈率为60%(p<0.05),酮康唑制剂治疗组超过80%(p<0.05)。
尽管本研究中应用含柠檬香茅精油制剂后观察到安全性和抗真菌作用,但仍需进行更大规模人群的进一步研究,以确认这些制剂在治疗花斑糠疹患者中的实际潜力。