Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2008-05-31
2009-06-30
Brief Summary
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To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.
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Detailed Description
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Oral Polypodium Leucotomos is safe and effective in patients with melasma.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Polypodium Leucotomos
Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.
Polypodium Leucotomos
Oral capsule at 240 mg taken twice a day for 12 weeks
Placebo
Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.
Placebo
240 mg Placebo taken orally twice daily created by company which manufactured active ingredient
Interventions
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Polypodium Leucotomos
Oral capsule at 240 mg taken twice a day for 12 weeks
Placebo
240 mg Placebo taken orally twice daily created by company which manufactured active ingredient
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of Miami
OTHER
Responsible Party
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University of Miami
Principal Investigators
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Heather Woolery-Lloyd, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Cosmetic Center
Miami, Florida, United States
Countries
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Other Identifiers
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20070050
Identifier Type: -
Identifier Source: org_study_id
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