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
About this trial
This is an interventional treatment trial for Melasma focused on measuring melasma, sunscreen, polypodium leucotomos
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
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
NCT ID
NCT01092884
First Posted
March 23, 2010
Last Updated
September 1, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Industrial Farmacéutica Cantabria, S.A.
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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