Oral Polypodium Leucotomos for Melasma

University of Miami21 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Melasma

Interventions

Polypodium LeucotomosDIETARY_SUPPLEMENT

Oral capsule at 240 mg taken twice a day for 12 weeks

PlaceboDIETARY_SUPPLEMENT

240 mg Placebo taken orally twice daily created by company which manufactured active ingredient

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami Cosmetic Center

Miami, Florida, United States

Outcomes

Primary Outcomes

Melasma Area and Severity Index (MASI)

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.

Time frame: Day 0, Week 4, Week 8, Week 12

Secondary Outcomes

Patient Assessment

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

Time frame: Week 4, Week 8, Week 12

Evaluation of Photographs

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

Time frame: Post-Week 12

Adverse Events

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

Time frame: Week 4, Week 8, Week 12

Data from ClinicalTrials.gov

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