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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polypodium Leucotomos | Active Comparator | Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks. |
|
| Placebo | Placebo Comparator | Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polypodium Leucotomos | Dietary Supplement | Oral capsule at 240 mg taken twice a day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Melasma Area and Severity Index (MASI) | 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. | Day 0, Week 4, Week 8, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Assessment | Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment. | Week 4, Week 8, Week 12 |
| Evaluation of Photographs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Woolery-Lloyd, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Cosmetic Center | Miami | Florida | 33140 | United States |
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| ID | Term |
|---|---|
| D008548 | Melanosis |
| ID | Term |
|---|---|
| D017495 | Hyperpigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo | Dietary Supplement | 240 mg Placebo taken orally twice daily created by company which manufactured active ingredient |
|
Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
| Post-Week 12 |
| Adverse Events | Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product. | Week 4, Week 8, Week 12 |