Melasma
Conditions
Keywords
Melasma
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.
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.
Interventions
DIETARY_SUPPLEMENTPolypodium Leucotomos
Oral capsule at 240 mg taken twice a day for 12 weeks
DIETARY_SUPPLEMENTPlacebo
240 mg Placebo taken orally twice daily created by company which manufactured active ingredient
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Melasma Area and Severity Index (MASI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed