Oral Polypodium Leucotomos for Melasma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01162850
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : August 5, 2011
Information provided by:
University of Miami

July 14, 2010
July 15, 2010
August 5, 2011
May 2008
June 2009   (Final data collection date for primary outcome measure)
Melasma Area and Severity Index (MASI) [ Time Frame: Day 0, Week 4, Week 8, Week 12 ]
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.
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Complete list of historical versions of study NCT01162850 on Archive Site
  • Patient Assessment [ Time Frame: Week 4, Week 8, Week 12 ]
    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 [ Time Frame: Post-Week 12 ]
    Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
  • Adverse Events [ Time Frame: Week 4, Week 8, Week 12 ]
    Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.
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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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Dietary Supplement: Polypodium Leucotomos
    Oral capsule at 240 mg taken twice a day for 12 weeks
  • Dietary Supplement: Placebo
    240 mg Placebo taken orally twice daily created by company which manufactured active ingredient
  • Active Comparator: Polypodium Leucotomos
    Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.
    Intervention: Dietary Supplement: Polypodium Leucotomos
  • Placebo Comparator: Placebo
    Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Heather Woolery-Lloyd, MD, University of Miami
University of Miami
Not Provided
Principal Investigator: Heather Woolery-Lloyd, MD University of Miami
University of Miami
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP