Oral Polypodium Leucotomos for Melasma - Full Text View

Purpose

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.

Condition	Intervention
Melasma	Dietary Supplement: Polypodium Leucotomos Dietary Supplement: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment
Official Title:	A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma

Further study details as provided by University of Miami:

Primary Outcome Measures:

Melasma Area and Severity Index (MASI) [ Time Frame: Day 0, Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Patient Assessment [ Time Frame: Week 4, Week 8, Week 12 ] [ Designated as safety issue: No ]
Subject critiqued their melasma as either getting worse, showing no improvement, mild improvement or as showing marked improvement upon using the treatment.
Evaluation of Photographs [ Time Frame: Post-Week 12 ] [ Designated as safety issue: No ]
Photos were evaluated using the grading of worse, no improvement, mild improvement or marked improvement comparing week 12 to baseline.
Adverse Events [ Time Frame: Week 4, Week 8, Week 12 ] [ Designated as safety issue: Yes ]
Recorded any and all adverse events that occurred even if it was unlikely that it was associated with the study product.

Enrollment:	21
Study Start Date:	May 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Polypodium Leucotomos Oral Polypodium Leucotomos twice daily plus sunscreen SPF 45 for 12 weeks.	Dietary Supplement: Polypodium Leucotomos Oral capsule at 240 mg taken twice a day for 12 weeks
Placebo Comparator: Placebo Oral Placebo twice daily plus sunscreen SPF 45 for 12 weeks.	Dietary Supplement: Placebo 240 mg Placebo taken orally twice daily created by company which manufactured active ingredient

Detailed Description:

Polypodium Leucotomos is a fern, also known as Calaguala used by the natives of northern Honduras as a treatment against malignant tumors Used in Spain and Central America for the treatment of psoriasis, atopic dermatitis and repigmentation of vitiligo.

Oral Polypodium Leucotomos is safe and effective in patients with melasma.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162850

Locations

United States, Florida
University of Miami Cosmetic Center
Miami, Florida, United States, 33140

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator:

Heather Woolery-Lloyd, MD

University of Miami

More Information

No publications provided

Responsible Party:	Heather Woolery-Lloyd, MD, University of Miami
ClinicalTrials.gov Identifier:	NCT01162850 History of Changes
Other Study ID Numbers:	20070050
Study First Received:	July 14, 2010
Last Updated:	August 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Miami:

Melasma

Additional relevant MeSH terms:

Melanosis
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013