Polypodium Leucotomos Extract for the Treatment of Melasma

Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01092884

Enrollment

Registered

2010-03-25

Start date

2010-03-31

Completion date

2012-07-31

Last updated

2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melasma

Keywords

melasma, sunscreen, polypodium leucotomos

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTPolypodium leucotomos extract

240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily

OTHERPlacebo

This placebo capsule will be taken orally three times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Hispanic female with moderate to severe facial melasma

Exclusion criteria

* Currently pregnant or breastfeeding * Recent use of hydroquinone, topical retinoids, topical steroids, or mechanically abrading procedures (such as laser therapy or dermabrasion) to the face * Frequent use of tanning parlors

Design outcomes

Primary

Measure	Time frame	Description
Mexameter score	12 weeks	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

Secondary

Measure	Time frame	Description
MASI Score	12 weeks	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
Melasma-Related Quality of Life	12 weeks	We will use a validated questionnaire tool to assess change in melasma-related quality of life at 12 weeks compared to baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026