Oral Polypodium Leucotomos for Melasma
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.
|Melasma||Dietary Supplement: Polypodium Leucotomos Dietary Supplement: Placebo|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
|Official Title:||A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma|
- Melasma Area and Severity Index (MASI) [ Time Frame: 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.
- Patient Assessment [ Time Frame: 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.
- Evaluation of Photographs [ Time Frame: Post-Week 12 ]Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
- Adverse Events [ Time Frame: 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.
|Study Start Date:||May 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162850
|United States, Florida|
|University of Miami Cosmetic Center|
|Miami, Florida, United States, 33140|
|Principal Investigator:||Heather Woolery-Lloyd, MD||University of Miami|