Oral Polypodium Leucotomos for Melasma

A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma

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.

Study Overview

• Status: Completed
• Conditions: Melasma
• Intervention / Treatment: Dietary supplement: Polypodium Leucotomos; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33140
      • University of Miami Cosmetic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Polypodium Leucotomos; Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.	Dietary supplement: Polypodium Leucotomos; Oral capsule at 240 mg taken twice a day for 12 weeks
Placebo Comparator: Placebo; Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.	Dietary supplement: Placebo; 240 mg Placebo taken orally twice daily created by company which manufactured active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0, Week 4, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Assessment	Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment.	Week 4, Week 8, Week 12
Evaluation of Photographs	Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.	Post-Week 12
Adverse Events	Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.	Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: University of Miami

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: July 14, 2010
• First Posted (Estimate): July 15, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2011
• Last Update Submitted That Met QC Criteria: August 4, 2011
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Melasma
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis
• Other Study ID Numbers: 20070050