Oral Polypodium Leucotomos for Melasma

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stareEfectuat

Sponsorii

University of Miami

STUDIU CLINIC: NCT01162850

BioSeek: NCT01162850

Cuvinte cheie

Abstract

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.

Descriere

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.

Datele

Ultima verificare:	06/30/2008
Primul depus:	07/13/2010
Inscriere estimată trimisă:	07/13/2010
Prima postare:	07/14/2010
Ultima actualizare trimisă:	08/03/2011
Ultima actualizare postată:	08/04/2011
Data actuală de începere a studiului:	04/30/2008
Data estimată de finalizare primară:	05/31/2009
Data estimată de finalizare a studiului:	05/31/2009

Stare sau boală

Melasma

Intervenție / tratament

Dietary Supplement: Polypodium Leucotomos

Dietary Supplement: Placebo

Fază

Grupuri de brațe

Braţ	Intervenție / tratament
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

Criterii de eligibilitate

Vârste eligibile pentru studiu	18 Years La 18 Years
Sexe eligibile pentru studiu	Female
Acceptă voluntari sănătoși	da
Criterii	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.

Rezultat

Măsuri de rezultate primare

1. Melasma Area and Severity Index (MASI) [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.

Măsuri de rezultate secundare

1. Patient Assessment [Week 4, Week 8, Week 12]

Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment.

2. Evaluation of Photographs [Post-Week 12]

Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.

3. Adverse Events [Week 4, Week 8, Week 12]

Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.

Oral Polypodium Leucotomos for Melasma

Cuvinte cheie

melasma

neoplasms

dermatită

melanosis

vitiligo

psoriazis

polypodium