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NCT07169383: Melasma
Oral Melatonin Versus Oral Tranexamic Acid in the Management of Melasma
Phase 2 trial testing Melatonin tablet in Melasma (Facial Melasma) in 160 participants. Enrolling by invitation.
28 December 2025
Quick facts
| Lead sponsor | Hina Malik |
|---|---|
| Phase | Phase 2 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 160 |
| Start date | 28 June 2025 |
| Primary completion | 28 December 2025 |
| Estimated completion | 28 December 2025 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- Melatonin tablet
- Tranexamic Acid (TXA) — full drug profile →
Conditions studied
- Melasma (Facial Melasma) — all drugs for Melasma (Facial Melasma) →
Sponsor
Hina Malik
Who can join
Adults 18 to 50, any sex, with Melasma (Facial Melasma). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will compare the efficacy of oral melatonin and oral tranexamic acid in treating melasma, with the aim of determining whether melatonin is more effective than tranexamic acid, as measured by MASI scores. Literature suggests melatonin may be more effective due to its antioxidant, anti-inflammatory, and anti-melanogenic properties. The findings will assess whether melatonin provides better efficacy and tolerance compared to tranexamic acid in managing this persistent condition. Efficacy will be assessed by comparing the baseline MASI scores with the scores obtained at six-week and twelve-week follow-up points based on the following cut-offs: \<25% improvement Mild response 25-50% improvement Moderate Response 51-75% improvement Good response \>75% improvement Excellent Response
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07169383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Melasma (Facial Melasma)
Currently open trials in the same condition.
- NCT07071363 — COMPARISON OF A COSMETIC SERUM AND 4% HYDROQUINONE FOR TREATING MELASMA OVER 84 DAYS · NA · recruiting
- NCT07202156 — Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma · NA · 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 NCT07169383 (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 Hina Malik
- Last refreshed: 11 September 2025
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/NCT07169383.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing