Oral Polypodium Leucotomos for Melasma

This study has been completed.
Sponsor:
Information provided by:
University of Miami
ClinicalTrials.gov Identifier:
NCT01162850
First received: July 14, 2010
Last updated: August 4, 2011
Last verified: July 2008
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014