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A PROSPECTIVE, RANDOMIZED AND OPEN LABEL STUDY TO COMPARE EFFICACY AND SAFETY OF TOPICAL GLUTATHIONE (2%) WITH TOPICAL TRANEXAMIC ACID (3%) IN ADULT MELASMA PATIENTS

A PROSPECTIVE, RANDOMIZED AND OPEN LABEL STUDY TO COMPARE EFFICACY AND SAFETY OF TOPICAL GLUTATHIONE (2%) WITH TOPICAL TRANEXAMIC ACID (3%) IN ADULT MELASMA PATIENTS - TGTTAS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050940
Enrollment
60
Registered
2023-05-04
Start date
2022-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MELASMA

Interventions

Topical Glutathione (2%), each time - amount sufficient for thin uniform film over face, BD (Twice daily - morning and evening) Topical tranexamic acid (3%), each time - amount sufficient for thin uni

Sponsors

DEPARTMENT OF PHARMACOLOGY, GOVERNMENT MEDICAL COLLEGE AMRITSAR
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Melasma patients diagnosed clinically Study subjects between eighteen to sixty years of age, irrespective of sex, socio-economic status and duration of lesions

Exclusion criteria

Exclusion criteria: Patients refusing to give written informed consent Hypersensitivity to test drugs Pregnancy and lactation Any major comorbidities Hormonal medication 3 months prior to study

Design outcomes

Primary

MeasureTime frame
Evaluation of efficacy of topical glutathione (2%) in comparison to topical tranexamic acid (3%) through evaluation by Modified Melasma Area Severity Index at baseline, 30, 60 and 90 days of study (mMASI) and Physician Global Assessment (PGA) scores at 30, 60 and 90 days of study

Secondary

MeasureTime frame
Evaluation of safety by documenting proportion of adverse effects in each group at 30, 60 and 90 days of study Evaluation of quality of life by Melasma Quality of Life Index (MELASQOL) at baseline and 90 days of study

Countries

Asia(except Japan)

Contacts

Public ContactDR SAURABH BIJALWAN

GOVERNMENT MEDICAL COLLEGE AMRITSAR PHARMACOLOGY

SOPHSHAN93@GMAIL.COM+917895168233

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026