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NCT01092884
Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma
NA trial testing Polypodium leucotomos extract in Melasma in 40 participants. Completed in 1 July 2012.
1 July 2011
Quick facts
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 March 2010 |
| Primary completion | 1 July 2011 |
| Estimated completion | 1 July 2012 |
Drugs / interventions tested
- Polypodium leucotomos extract
- Placebo
Conditions studied
- Melasma — all drugs for Melasma →
Sponsor
University of Texas Southwestern Medical Center
Who can join
18 and older, 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.
-
Mexameter score
Time frame: 12 weeks
Using rapid, non-invasive, narrow-band reflectance spectrophotometry (Mexameter), we will assess change in intensity of pigment in affected skin versus unaffected skin at 12 weeks
Sponsor's own description
We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Interventions for melasma.
Rajaratnam R, Halpern J, Salim A, Emmett C. · · 2010 · cited 37× · PMID 20614435 · DOI 10.1002/14651858.cd003583.pub2
Verify or expand the search:
- PubMed search for NCT01092884
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Melasma
Currently open trials in the same condition.
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- 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 Texas Southwestern Medical Center trials
Trials by the same sponsor.
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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 NCT01092884 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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 Texas Southwestern Medical Center
- Last refreshed: 1 September 2023
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/NCT01092884.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing