Polypodium Leucotomos Extract for the Treatment of Melasma

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

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.

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Dietary supplement: Polypodium leucotomos extract; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Industrial Farmacéutica Cantabria, S.A.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 23, 2010
• First Submitted That Met QC Criteria: March 23, 2010
• First Posted (Estimated): March 25, 2010

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: melasma; sunscreen; polypodium leucotomos
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: 092009-036