Oral Polypodium Leucotomos for Melasma

Not Applicable

Completed

• Conditions: Melasma
• Interventions: Dietary Supplement: Polypodium Leucotomos; Dietary Supplement: Placebo

• Registration Number: NCT01162850
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2008-05
• Status Verified: 2008-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2010-07-14
• Study First Posted: 2010-07-15
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polypodium Leucotomos	Polypodium Leucotomos	Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.
Placebo	Placebo	Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

University of Miami Cosmetic Center; 🇺🇸 Miami, Florida, United States