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Polypodium Leucotomos Extract for the Treatment of Melasma

Primary Purpose

Melasma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Polypodium leucotomos extract
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring melasma, sunscreen, polypodium leucotomos

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Polypodium leucotomos

    Sugar pill

    Arm Description

    Subjects randomized to this arm will receive oral supplementation with Polypodium leucotomos extract

    Subjects randomized to this arm will receive oral supplementation with placebo

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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

    Full Information

    First Posted
    March 23, 2010
    Last Updated
    September 1, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    Industrial Farmacéutica Cantabria, S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01092884
    Brief Title
    Polypodium Leucotomos Extract for the Treatment of Melasma
    Official Title
    Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    Industrial Farmacéutica Cantabria, S.A.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Melasma
    Keywords
    melasma, sunscreen, polypodium leucotomos

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Polypodium leucotomos
    Arm Type
    Active Comparator
    Arm Description
    Subjects randomized to this arm will receive oral supplementation with Polypodium leucotomos extract
    Arm Title
    Sugar pill
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects randomized to this arm will receive oral supplementation with placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Polypodium leucotomos extract
    Other Intervention Name(s)
    Heliocare
    Intervention Description
    240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    This placebo capsule will be taken orally three times daily
    Primary Outcome Measure Information:
    Title
    Mexameter score
    Description
    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
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    MASI Score
    Description
    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
    Time Frame
    12 weeks
    Title
    Melasma-Related Quality of Life
    Description
    We will use a validated questionnaire tool to assess change in melasma-related quality of life at 12 weeks compared to baseline
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Polypodium Leucotomos Extract for the Treatment of Melasma

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