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Polypodium Leucotomos Extract for the Treatment of Melasma

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ClinicalTrials.gov Identifier: NCT01092884
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : July 25, 2012
Sponsor:
Collaborator:
Industrial Farmaceutica Cantabria, Spain
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Melasma Dietary Supplement: Polypodium leucotomos extract Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma
Study Start Date : March 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure
U.S. FDA Resources

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 Name: 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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01092884     History of Changes
Other Study ID Numbers: 092009-036
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: July 25, 2012
Last Verified: March 2010

Keywords provided by University of Texas Southwestern Medical Center:
melasma
sunscreen
polypodium leucotomos

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases