Oral Polypodium Leucotomos for Melasma
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 06/30/2008 |
| Pirmasis pateikimas: | 07/13/2010 |
| Numatytas registravimas pateiktas: | 07/13/2010 |
| Pirmas paskelbtas: | 07/14/2010 |
| Paskutinis atnaujinimas pateiktas: | 08/03/2011 |
| Paskutinis atnaujinimas paskelbtas: | 08/04/2011 |
| Faktinė studijų pradžios data: | 04/30/2008 |
| Numatoma pirminio užbaigimo data: | 05/31/2009 |
| Numatoma studijų užbaigimo data: | 05/31/2009 |
Būklė ar liga
Intervencija / gydymas
Dietary Supplement: Polypodium Leucotomos
Dietary Supplement: Placebo
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| 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 |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | Female |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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. |
Rezultatas
Pirminės rezultatų priemonės
1. Melasma Area and Severity Index (MASI) [Day 0, Week 4, Week 8, Week 12]
Antrinės rezultatų priemonės
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]
