Handog Evangeline B, Galang Dulce Amor Vivan F, de Leon-Godinez Maria Azirrel, Chan Gertrude P
The Section of Dermatology, Department of Health, Research Institute for Tropical Medicine, Manila, Philippines.
Int J Dermatol. 2009 Aug;48(8):896-901. doi: 10.1111/j.1365-4632.2009.04130.x.
Melasma is a common, acquired, symmetric hypermelanosis characterized by irregular brown to gray-brown macules on the cheeks, forehead, nasal bridge, cutaneous part of the upper lip, mandible, and the upper arms. Few trials have been conducted regarding the potential benefits of oral procyanidin in melasma.
To assess the safety and efficacy of oral procyanidin + vitamins A, C, E among Filipino patients with epidermal melasma.
A randomized, double-blind, placebo-controlled trial lasting 8 weeks, involving 60 adult female volunteers with bilateral epidermal melasma, Fitzpatrick skin types III-V, was conducted at the Section of Dermatology, Research Institute for Tropical Medicine, Department of Health, Manila, Philippines. Patients received either the test drug or placebo, twice daily with meals. Changes in pigmentation were measured using a mexameter, the melasma area and severity index (MASI), and a global evaluation by the patient and investigator. Safety evaluations were performed at each follow-up visit.
Fifty-six patients completed the trial. Mexameter results demonstrated a significant decrease in the degree of pigmentation in the left malar (165.85 +/- 70.909) and right malar (161.33 +/- 61.824) regions (P < 0.0001). MASI scores showed a significant improvement in the left malar (2.4862 +/- 1.67816) and right malar (1.8889 +/- 1.67110) regions (P = 0.001). Procyanidin + vitamins A, C, E proved to be safe and well tolerated, with minimal adverse events.
In this 8-week trial period, oral procyanidin + vitamins A, C, E proved to be safe and effective among Filipino women with epidermal melasma.
黄褐斑是一种常见的、后天性、对称性色素沉着过度疾病，其特征为脸颊、前额、鼻梁、上唇皮肤部分、下颌和上臂出现不规则的棕色至灰棕色斑疹。关于口服原花青素对黄褐斑的潜在益处，所做的试验很少。
评估口服原花青素+维生素A、C、E对菲律宾表皮型黄褐斑患者的安全性和疗效。
在菲律宾马尼拉市卫生部热带医学研究所皮肤病科进行了一项为期8周的随机、双盲、安慰剂对照试验，纳入60名患有双侧表皮型黄褐斑、皮肤 Fitzpatrick 分型为III - V型的成年女性志愿者。患者每日两次随餐服用受试药物或安慰剂。使用皮肤黑色素仪、黄褐斑面积和严重程度指数（MASI）以及患者和研究者的整体评估来测量色素沉着变化。每次随访时进行安全性评估。
56名患者完成了试验。皮肤黑色素仪结果显示，左颊（165.85 +/- 70.909）和右颊（161.33 +/- 61.824）区域的色素沉着程度显著降低（P < 0.0001）。MASI评分显示，左颊（2.4862 +/- 1.67816）和右颊（1.8889 +/- 1.67110）区域有显著改善（P = 0.001）。原花青素+维生素A、C、E被证明是安全的且耐受性良好，不良事件极少。
在这个为期8周的试验期内，口服原花青素+维生素A、C、E对患有表皮型黄褐斑的菲律宾女性被证明是安全有效的。
