Oral Polypodium Leucotomos for Melasma
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 06/30/2008 |
| Primero enviado: | 07/13/2010 |
| Inscripción estimada enviada: | 07/13/2010 |
| Publicado por primera vez: | 07/14/2010 |
| Última actualización enviada: | 08/03/2011 |
| Última actualización publicada: | 08/04/2011 |
| Fecha de inicio real del estudio: | 04/30/2008 |
| Fecha estimada de finalización primaria: | 05/31/2009 |
| Fecha estimada de finalización del estudio: | 05/31/2009 |
Condición o enfermedad
Intervención / tratamiento
Dietary Supplement: Polypodium Leucotomos
Dietary Supplement: Placebo
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| 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 |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | 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. |
Salir
Medidas de resultado primarias
1. Melasma Area and Severity Index (MASI) [Day 0, Week 4, Week 8, Week 12]
Medidas de resultado secundarias
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]
