Polypodium Leucotomos Extract for the Treatment of Melasma

Not Applicable

Completed

• Conditions: Melasma
• Interventions: Other: Placebo; Dietary Supplement: Polypodium leucotomos extract

• Registration Number: NCT01092884
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study Start: 2010-03
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-23
• Study First Posted: 2010-03-25
• Primary Completion: 2011-07
• Study Completion: 2012-07
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Placebo	Subjects randomized to this arm will receive oral supplementation with placebo
Polypodium leucotomos	Polypodium leucotomos extract	Subjects randomized to this arm will receive oral supplementation with Polypodium leucotomos extract

Primary Outcome Measures

Name	Time	Method
Mexameter score	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
MASI Score	12 weeks	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
Melasma-Related Quality of Life	12 weeks	We will use a validated questionnaire tool to assess change in melasma-related quality of life at 12 weeks compared to baseline