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Polypodium Leucotomos Extract for the Treatment of Melasma

The University of Texas System (UT) logo

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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