Oral Polypodium Leucotomos for Melasma

רק משתמשים רשומים יכולים לתרגם מאמרים

התחבר הרשם

הקישור נשמר בלוח

סטָטוּסהושלם

נותני חסות

University of Miami

ניסוי קליני: NCT01162850

BioSeek: NCT01162850

מילות מפתח

תַקצִיר

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.

תיאור

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.

תאריכים

אומת לאחרונה:	06/30/2008
הוגש לראשונה:	07/13/2010
ההרשמה המשוערת הוגשה:	07/13/2010
פורסם לראשונה:	07/14/2010
העדכון האחרון הוגש:	08/03/2011
עדכון אחרון פורסם:	08/04/2011
תאריך תחילת לימוד בפועל:	04/30/2008
תאריך סיום משוער משוער:	05/31/2009
תאריך סיום משוער ללימודים:	05/31/2009

מצב או מחלה

Melasma

התערבות / טיפול

Dietary Supplement: Polypodium Leucotomos

Dietary Supplement: Placebo

שלב

קבוצות זרועות

זְרוֹעַ	התערבות / טיפול
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

קריטריונים לזכאות

גילאים הזכאים ללימודים	18 Years ל 18 Years
מינים הזכאים ללימודים	Female
מקבל מתנדבים בריאים	כן
קריטריונים	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.

תוֹצָאָה

מדדי תוצאות ראשוניים

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.

אמצעי תוצאה משניים

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

מילות מפתח

melasma

סרטן

דרמטיטיס

melanosis

ויטיליגו

פסוריאזיס

polypodium