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Oral Polypodium Leucotomos for Melasma

Primary Purpose

Melasma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polypodium Leucotomos
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melasma focused on measuring Melasma

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy female subjects 18-50 years of age.
  • Female subjects with epidermal melasma.
  • Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.
  • Subjects with Fitzpatrick skin types II, III, & IV
  • Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.

Exclusion Criteria:

  • Pregnant or lactating
  • Dermal Melasma
  • Hormonal therapies less than or equal too 4 weeks prior to study
  • Use of photosensitizing medications
  • Simultaneous use of any form of treatment for melasma
  • Subjects who were concurrently receiving light therapies
  • Subjects who were unwilling to limit the amount of sun exposure
  • Simultaneous ( or past 30 day) participation in a clinical research study.

Sites / Locations

  • University of Miami Cosmetic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Polypodium Leucotomos

Placebo

Arm Description

Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.

Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.

Outcomes

Primary Outcome Measures

Melasma Area and Severity Index (MASI)
The following equation is used to determine the MASI score: MASI = .3A(D+H) [forhead] + .3A(D+H)[right malar] + .3A(D+H)[left malar] + .1A(D+H)[chin]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.

Secondary Outcome Measures

Patient Assessment
Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment.
Evaluation of Photographs
Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
Adverse Events
Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.

Full Information

First Posted
July 14, 2010
Last Updated
August 4, 2011
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT01162850
Brief Title
Oral Polypodium Leucotomos for Melasma
Official Title
A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma. To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.
Detailed Description
Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo. Oral Polypodium Leucotomos is safe and effective in patients with melasma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
Keywords
Melasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polypodium Leucotomos
Arm Type
Active Comparator
Arm Description
Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Polypodium Leucotomos
Intervention Description
Oral capsule at 240 mg taken twice a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
240 mg Placebo taken orally twice daily created by company which manufactured active ingredient
Primary Outcome Measure Information:
Title
Melasma Area and Severity Index (MASI)
Description
The following equation is used to determine the MASI score: MASI = .3A(D+H) [forhead] + .3A(D+H)[right malar] + .3A(D+H)[left malar] + .1A(D+H)[chin]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.
Time Frame
Day 0, Week 4, Week 8, Week 12
Secondary Outcome Measure Information:
Title
Patient Assessment
Description
Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment.
Time Frame
Week 4, Week 8, Week 12
Title
Evaluation of Photographs
Description
Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
Time Frame
Post-Week 12
Title
Adverse Events
Description
Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.
Time Frame
Week 4, Week 8, Week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy female subjects 18-50 years of age. Female subjects with epidermal melasma. Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study. Subjects with Fitzpatrick skin types II, III, & IV Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma. Exclusion Criteria: Pregnant or lactating Dermal Melasma Hormonal therapies less than or equal too 4 weeks prior to study Use of photosensitizing medications Simultaneous use of any form of treatment for melasma Subjects who were concurrently receiving light therapies Subjects who were unwilling to limit the amount of sun exposure Simultaneous ( or past 30 day) participation in a clinical research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Woolery-Lloyd, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Cosmetic Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States

12. IPD Sharing Statement

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Oral Polypodium Leucotomos for Melasma

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