Oral Polypodium Leucotomos for Melasma

• Patient Assessment [ Time Frame: Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: Yes ]
  Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.

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.

• 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

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.