Oral Polypodium Leucotomos for Melasma

• ClinicalTrials.gov Identifier: NCT01162850
• Recruitment Status: Completed
• First Posted: July 15, 2010
• Last Update Posted: August 5, 2011
• Sponsor: University of Miami
• Information provided by: University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Melasma	Dietary Supplement: Polypodium Leucotomos; Dietary Supplement: Placebo	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• 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
• Study Start Date: May 2008
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Melasma Area and Severity Index (MASI) [ Time Frame: Day 0, Week 4, Week 8, Week 12 ]
   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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes 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

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

• Responsible Party: Heather Woolery-Lloyd, MD, University of Miami
• ClinicalTrials.gov Identifier: NCT01162850
• Other Study ID Numbers: 20070050
• First Posted: July 15, 2010
• Last Update Posted: August 5, 2011
• Last Verified: July 2008

Keywords provided by University of Miami:

Melasma

Additional relevant MeSH terms:

Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases