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Completed

NCT Number: NCT01162850

Oral Polypodium Leucotomos for 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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Cosmetic Center

Miami, Florida, 33140, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polypodium Leucotomos

Dietary Supplement

Oral capsule at 240 mg taken twice a day for 12 weeks

Placebo

Dietary Supplement

240 mg Placebo taken orally twice daily created by company which manufactured active ingredient

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 15, 2010
Registry last updated
Aug 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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