NCT01092884

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 6, 2023

Status Verified

March 1, 2010

Enrollment Period

1.3 years

First QC Date

March 23, 2010

Last Update Submit

September 1, 2023

Conditions

Melasma

Keywords

melasmasunscreenpolypodium leucotomos

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • MASI Score

    12 weeks

  • Melasma-Related Quality of Life

    12 weeks

Study Arms (2)

Polypodium leucotomos

ACTIVE COMPARATOR

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

Dietary Supplement: Polypodium leucotomos extract

Sugar pill

PLACEBO COMPARATOR

Subjects randomized to this arm will receive oral supplementation with placebo

Other: Placebo

Interventions

Polypodium leucotomos extractDIETARY_SUPPLEMENT

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

Also known as: Heliocare
Polypodium leucotomos
PlaceboOTHER

This placebo capsule will be taken orally three times daily

Sugar pill

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hispanic female with moderate to severe facial melasma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 25, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2012

Last Updated

September 6, 2023

Record last verified: 2010-03