Polypodium Leucotomos Extract for the Treatment of Melasma

NCT ID: NCT01092884

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Polypodium leucotomos

Subjects randomized to this arm will receive oral supplementation with Polypodium leucotomos extract

Group Type ACTIVE_COMPARATOR

Polypodium leucotomos extract

Intervention Type DIETARY_SUPPLEMENT

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

Sugar pill

Subjects randomized to this arm will receive oral supplementation with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

This placebo capsule will be taken orally three times daily

Interventions

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Polypodium leucotomos extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

This placebo capsule will be taken orally three times daily

Intervention Type OTHER

Other Intervention Names

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Heliocare

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Industrial Farmacéutica Cantabria, S.A.

INDUSTRY

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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092009-036

Identifier Type: -

Identifier Source: org_study_id

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