Oral Polypodium Leucotomos for Melasma
Maneno muhimu
Kikemikali
Maelezo
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.
Tarehe
Imethibitishwa Mwisho: | 06/30/2008 |
Iliyowasilishwa Kwanza: | 07/13/2010 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 07/13/2010 |
Iliyotumwa Kwanza: | 07/14/2010 |
Sasisho la Mwisho Liliwasilishwa: | 08/03/2011 |
Sasisho la Mwisho Lilichapishwa: | 08/04/2011 |
Tarehe halisi ya kuanza kwa masomo: | 04/30/2008 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 05/31/2009 |
Tarehe ya Kukamilisha Utafiti: | 05/31/2009 |
Hali au ugonjwa
Uingiliaji / matibabu
Dietary Supplement: Polypodium Leucotomos
Dietary Supplement: Placebo
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
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 |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
Jinsia Inastahiki Kujifunza | Female |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | 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. |
Matokeo
Hatua za Matokeo ya Msingi
1. Melasma Area and Severity Index (MASI) [Day 0, Week 4, Week 8, Week 12]
Hatua za Matokeo ya Sekondari
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]