Oral Polypodium Leucotomos for Melasma

NCT01162850 | Completed

• 1 other identifier: 20070050
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To determine whether there is improvement in the melasma of participants taking oral Polypodium Leucotomos Secondary Objective: To determine whether oral Polypodium Leucotomos is well tolerated in study subjects with melasma. To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.

Conditions

Melasma

Keywords

Melasma

Outcome Measures

Primary Outcomes (1)

• Melasma Area and Severity Index (MASI)

  The following equation is used to determine the MASI score: MASI = .3A(D+H) \[forhead\] + .3A(D+H)\[right malar\] + .3A(D+H)\[left malar\] + .1A(D+H)\[chin\]; A = area, D = darkness, and H = homogeneity. Area is based on percentage of the region covered by melasma using a 1-6 scale. Darkness is determined on a 0-3 scale. Homogeneity is based on a 0-4 scale.

  Day 0, Week 4, Week 8, Week 12

Secondary Outcomes (3)

• Patient Assessment

  Week 4, Week 8, Week 12

• Evaluation of Photographs

  Post-Week 12

• Adverse Events

  Week 4, Week 8, Week 12

Study Arms (2)

Polypodium Leucotomos

ACTIVE COMPARATOR

Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.

Dietary Supplement: Polypodium Leucotomos

Placebo

PLACEBO COMPARATOR

Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.

Dietary Supplement: Placebo

Interventions

Polypodium Leucotomos DIETARY_SUPPLEMENT

Oral capsule at 240 mg taken twice a day for 12 weeks

Polypodium Leucotomos

Placebo DIETARY_SUPPLEMENT

240 mg Placebo taken orally twice daily created by company which manufactured active ingredient

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female subjects 18-50 years of age.
• Female subjects with epidermal melasma.
• Female subjects of child-bearing potential must have been willing to use an acceptable form of birth control for the duration of the study.
• Subjects with Fitzpatrick skin types II, III, \& IV
• Subjects enrolled in this trial had a 2 week washout period if on prior treatment for melasma.

You may not qualify if:

• Pregnant or lactating
• Dermal Melasma
• Hormonal therapies less than or equal too 4 weeks prior to study
• Use of photosensitizing medications
• Simultaneous use of any form of treatment for melasma
• Subjects who were concurrently receiving light therapies
• Subjects who were unwilling to limit the amount of sun exposure
• Simultaneous ( or past 30 day) participation in a clinical research study.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Cosmetic Center

Miami, Florida, 33140, United States

Location

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Heather Woolery-Lloyd, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: May 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 5, 2011

Record last verified: 2008-07

Locations

US (1)