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Completed

NCT Number: NCT01092884

Polypodium Leucotomos Extract 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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polypodium leucotomos extract

Dietary Supplement

240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily

Other names: Heliocare

Placebo

Other

This placebo capsule will be taken orally three times daily

Primary outcomes

  1. Mexameter score

    Time frame: 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 outcomes

  1. MASI Score

    Time frame: 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

  2. Melasma-Related Quality of Life

    Time frame: 12 weeks

    We will use a validated questionnaire tool to assess change in melasma-related quality of life at 12 weeks compared to baseline

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Industrial Farmacéutica Cantabria, S.A.

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Mar 25, 2010
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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