Oral Polypodium Leucotomos for Melasma

Melasma Clinical Trial

Official title:

A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162850
• Other study ID #: 20070050
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: August 4, 2011
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2008
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melasma

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
United States	University of Miami Cosmetic Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

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