A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Melasma Area and Severity Index (MASI)
研究概览
简要总结
Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma.
To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.
详细描述
Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.
Oral Polypodium Leucotomos is safe and effective in patients with melasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects 18-50 years of age.
- •Female subjects with epidermal melasma.
- •Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.
- •Subjects with Fitzpatrick skin types II, III, & IV
- •Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.
排除标准
- •Pregnant or lactating
- •Dermal Melasma
- •Hormonal therapies less than or equal too 4 weeks prior to study
- •Use of photosensitizing medications
- •Simultaneous use of any form of treatment for melasma
- •Subjects who were concurrently receiving light therapies
- •Subjects who were unwilling to limit the amount of sun exposure
- •Simultaneous ( or past 30 day) participation in a clinical research study.
结局指标
主要结局
Melasma Area and Severity Index (MASI)
时间窗: Day 0, Week 4, Week 8, Week 12
The following equation is used to determine the MASI score: MASI = .3A(D+H) \[forhead\] + .3A(D+H)\[right malar\] + .3A(D+H)\[left malar\] + .1A(D+H)\[chin\]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.
次要结局
- Patient Assessment(Week 4, Week 8, Week 12)
- Evaluation of Photographs(Post-Week 12)
- Adverse Events(Week 4, Week 8, Week 12)