Oral Polypodium Leucotomos for Melasma
关键词
抽象
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.
日期
| 最后验证: | 06/30/2008 |
| 首次提交: | 07/13/2010 |
| 提交的预估入学人数: | 07/13/2010 |
| 首次发布: | 07/14/2010 |
| 上次提交的更新: | 08/03/2011 |
| 最近更新发布: | 08/04/2011 |
| 实际学习开始日期: | 04/30/2008 |
| 预计主要完成日期: | 05/31/2009 |
| 预计完成日期: | 05/31/2009 |
状况或疾病
干预/治疗
Dietary Supplement: Polypodium Leucotomos
Dietary Supplement: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Polypodium Leucotomos Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks. | Dietary Supplement: Polypodium Leucotomos Oral capsule at 240 mg taken twice a day for 12 weeks |
| Placebo Comparator: Placebo Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks. | Dietary Supplement: Placebo 240 mg Placebo taken orally twice daily created by company which manufactured active ingredient |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
结果
主要结果指标
1. Melasma Area and Severity Index (MASI) [Day 0, Week 4, Week 8, Week 12]
次要成果指标
1. Patient Assessment [Week 4, Week 8, Week 12]
2. Evaluation of Photographs [Post-Week 12]
3. Adverse Events [Week 4, Week 8, Week 12]
