Oral Polypodium Leucotomos for Melasma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma

Conditions
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Melasma

Intervention / Treatment
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* Dietary Supplement: Polypodium Leucotomos
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polypodium Leucotomos<br>Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks. | Dietary Supplement: Polypodium Leucotomos<br>* Oral capsule at 240 mg taken twice a day for 12 weeks<br>|
| Placebo Comparator: Placebo<br>Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks. | Dietary Supplement: Placebo<br>* 240 mg Placebo taken orally twice daily created by company which manufactured active ingredient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 0, Week 4, Week 8, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment | Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment. | 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. | 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. | Week 4, Week 8, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melasma