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| Name | Class |
|---|---|
| Industrial Farmacéutica Cantabria, S.A. | INDUSTRY |
We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polypodium leucotomos | Active Comparator | Subjects randomized to this arm will receive oral supplementation with Polypodium leucotomos extract |
|
| Sugar pill | Placebo Comparator | Subjects randomized to this arm will receive oral supplementation with placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polypodium leucotomos extract | Dietary Supplement | 240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mexameter score | Using rapid, non-invasive, narrow-band reflectance spectrophotometry (Mexameter), we will assess change in intensity of pigment in affected skin versus unaffected skin at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| MASI Score | We will use the standardized Melasma Area and Severity Index (MASI) score, assessed by blinded physician investigator, to assess change in severity of melasma at 12 weeks compared to baseline | 12 weeks |
| Melasma-Related Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Other | This placebo capsule will be taken orally three times daily |
|
We will use a validated questionnaire tool to assess change in melasma-related quality of life at 12 weeks compared to baseline
| 12 weeks |