Polypodium Leucotomos Extract for the Treatment of Melasma

This study has been completed.
Sponsor:
Collaborator:
Industrial Farmaceutica Cantabria, Spain
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01092884
First received: March 23, 2010
Last updated: July 23, 2012
Last verified: March 2010
  Purpose

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 Intervention
Melasma
Dietary Supplement: Polypodium leucotomos extract
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Mexameter score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    We will use a validated questionnaire tool to assess change in melasma-related quality of life at 12 weeks compared to baseline


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01092884     History of Changes
Other Study ID Numbers: 092009-036
Study First Received: March 23, 2010
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014