Polypodium Leucotomos Extract for the Treatment of Melasma

The University of Texas System (UT)

Status: Completed

Conditions: Melasma

Treatments: Dietary Supplement: Polypodium leucotomos extract; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01092884

092009-036

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Polypodium leucotomos

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Polypodium leucotomos extract

Sugar pill

Placebo Comparator group

Description:

Subjects randomized to this arm will receive oral supplementation with placebo

Treatment:

Other: Placebo