Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-05 @ 1:45 PM
Study NCT ID:
NCT01162850
Status:
COMPLETED
Last Update Posted:
2011-08-05
First Post:
2010-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Polypodium Leucotomos for Melasma
Sponsor:
University of Miami
Organization:
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
To determine whether treatment with Polypodium Leucotomos improves the health-related quality of life.
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.
Oral Polypodium Leucotomos is safe and effective in patients with melasma.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: