Polypodium Leucotomos Extract for the Treatment of Melasma

Melasma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092884
• Other study ID #: 092009-036
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2010
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanosis
• Melasma

Intervention

Dietary Supplement:
• Polypodium leucotomos extract
240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily

Other:
• Placebo
This placebo capsule will be taken orally three times daily

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Industrial Farmacéutica Cantabria, S.A.

Outcome

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