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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01162850
Other study ID # 20070050
Secondary ID
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


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
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