Polypodium Leucotomos Extract for the Treatment of Melasma

Study Overview
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Brief Summary
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We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.

Official Title
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Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma

Conditions
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Melasma

Intervention / Treatment
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* Dietary Supplement: Polypodium leucotomos extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hispanic female with moderate to severe facial melasma Exclusion Criteria: Currently pregnant or breastfeeding Recent use of hydroquinone, topical retinoids, topical steroids, or mechanically abrading procedures (such as laser therapy or dermabrasion) to the face Frequent use of tanning parlors

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Polypodium leucotomos<br>Subjects randomized to this arm will receive oral supplementation with Polypodium leucotomos extract | Dietary Supplement: Polypodium leucotomos extract<br>* 240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily<br>* Other names: Heliocare;|
| Placebo Comparator: Sugar pill<br>Subjects randomized to this arm will receive oral supplementation with placebo | Other: Placebo<br>* This placebo capsule will be taken orally three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mexameter score | Using rapid, non-invasive, narrow-band reflectance spectrophotometry (Mexameter), we will assess change in intensity of pigment in affected skin versus unaffected skin at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MASI Score | We will use the standardized Melasma Area and Severity Index (MASI) score, assessed by blinded physician investigator, to assess change in severity of melasma at 12 weeks compared to baseline | 12 weeks | 
| Melasma-Related Quality of Life | We will use a validated questionnaire tool to assess change in melasma-related quality of life at 12 weeks compared to baseline | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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melasma, sunscreen, polypodium leucotomos