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NCT01162850
A Randomized Double-Blind Placebo Controlled Study Evaluating the Effectiveness and Tolerability of Oral Polypodium Leucotomos in Patients With Melasma
NA trial testing Polypodium Leucotomos in Melasma in 21 participants. Completed in 1 June 2009.
1 June 2009
Quick facts
| Lead sponsor | University of Miami |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 1 May 2008 |
| Primary completion | 1 June 2009 |
| Estimated completion | 1 June 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Polypodium Leucotomos — full drug profile →
- Placebo
Conditions studied
- Melasma — all drugs for Melasma →
Sponsor
University of Miami
Who can join
Adults 18 to 50, female only, with Melasma. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01162850
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Polypodium Leucotomos
Trials testing the same drug.
- NCT02904798 — The Effects of Visible Light on the Skin After Administration of Oral Polypodium Leucotomos · NA · completed
Other recruiting trials for Melasma
Currently open trials in the same condition.
- NCT06845540 — Oral Metformin for Treating Melasma in Latin American Women · Phase 1, PHASE2 · recruiting
- NCT06644157 — Treatment and Prevention of Melasma Relapses by Using 1064nm 650 Microsecond Laser · NA · active not recruiting
- NCT07034560 — Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma · Phase 4 · active not recruiting
- NCT06516419 — Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy · NA · recruiting
- NCT05942248 — The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis · NA · recruiting
Other University of Miami trials
Trials by the same sponsor.
- NCT06003712 — Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI) · NA · not yet recruiting
- NCT06077071 — MRIdian "RADAR" Trial · NA · not yet recruiting
- NCT07472413 — Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project · Phase 3 · not yet recruiting
- NCT07322289 — Antibiotic-coated Braided Suture Study · NA · not yet recruiting
- NCT07469592 — eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01162850 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Miami
- Last refreshed: 4 August 2011
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01162850.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing