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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

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.

Condition or disease Intervention/treatment Phase
Melasma Dietary Supplement: Polypodium Leucotomos Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01162850

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United States, Florida
University of Miami Cosmetic Center
Miami, Florida, United States, 33140
Sponsors and Collaborators
University of Miami
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Principal Investigator: Heather Woolery-Lloyd, MD University of Miami
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Responsible Party: Heather Woolery-Lloyd, MD, University of Miami Identifier: NCT01162850    
Other Study ID Numbers: 20070050
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: July 2008
Keywords provided by University of Miami:
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases