Comparative Study of mMASI Before and After Hyperthyroid Therapy in Hyperthyroid Subjects With Melasma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- mMASI (modified melasma area and severity index)
研究概览
简要总结
Study's objectives are to determine proportion of melasma cases in hyperthyroid patients and to compare severity of melasma before and after medications of three months hyperthyroid therapy using modified melasma area and severity index (mMASI) score. A quasi experimental (pre-post intervention) study was conducted in Jakarta in August 2019-February 2020.
详细描述
Melasma is an acquired and chronic disorder of hyperpigmentation characterized by symmetrical hypermelanoses of the face. The exact pathogenesis of melasma is still unknown. Several hormones are thought to play a role, including thyroid hormone. Although melasma is not life-threatening, it affects greatly on the quality of life of patients. Study's objectives are to determine proportion of melasma cases in hyperthyroid patients and to compare severity of melasma before and after medications of three months hyperthyroid therapy using mMASI score. An experimental (before and after) study was conducted in Jakarta in August 2019-February 2020. Twenty three newly-diagnosed hyperthyroid patients or had taken hyperthyroid medications of maximum 3 months with melasma were recruited. The severity of melasma were scored with mMASI and dermoscopy of the lesions were collected. The same procedures were done after 3 months of hyperthyroid therapy. The data collected was statistically analyzed using Stata version 15.0
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female with age range of 18 to 60 years old
- •Newly diagnosed with hyperthyroid on a laboratory basis
- •Diagnosed with melasma by dermatologist
排除标准
- •Pregnant or breastfeeding
- •Using hormonal contraception or history of using hormonal contraception within 1 year
- •On anti-seizure therapy or hormone replacement therapy
- •History of drug use that can affect the thyroid
- •History of using topical hydroquinone in the last 3 months and / or using a topical steroid and / or an vitamin A analog and / or received chemical peeling in the last 1 month
- •History of laser therapy and / or mechanical abrasion therapy in the past 9 months
研究组 & 干预措施
Single Intervention
Before-and-After type of research
干预措施: Thiamazol (Drug)
结局指标
主要结局
mMASI (modified melasma area and severity index)
时间窗: 3 months after taking the hyperthyroid drugs
mMASI Score (modified melasma area and severity index); value 0-24; smaller score means better outcome
次要结局
未报告次要终点
研究者
Dr.dr.Irma Bernadette, SpKK (K)
Irma Bernadette S. Sitohang, MD, PhD - Head of Division of Cosmetic Dermatology, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Indonesia University