NCT07522788

Brief Summary

This study is to compare the efficacy of topical tranexamic acid vs topical ethyl ascorbic acid in the treatment of melasma

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
6mo left

Started Jun 2026

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 4, 2026

Last Update Submit

April 4, 2026

Conditions

Melasma

Keywords

Melasma

Outcome Measures

Primary Outcomes (1)

  • Assessment of Melasma Area Index Score

    We will assist the improvement in hyperpigmented patches of melasma based on MASI

    6 months

Study Arms (2)

ethyl ascorbic acid Group

ACTIVE COMPARATOR

The participants in this arm will receive only topical ethyl ascorbic acid

Drug: Ethyl ascorbic acid topical applicationDrug: Tranxemic acid topical application

Topical tranexamic acid group

ACTIVE COMPARATOR

Participants in this group will receive only topical tranexamic acid

Drug: Ethyl ascorbic acid topical applicationDrug: Tranxemic acid topical application

Interventions

Ethyl ascorbic acid topical applicationDRUG

The participants in this arm of study will only receive topical ethyl ascorbic acid once daily at night for 12 weeks

Topical tranexamic acid groupethyl ascorbic acid Group
Tranxemic acid topical applicationDRUG

The participants in this arm will receive only topical tranexamic acid once daily for 12 weeks

Topical tranexamic acid groupethyl ascorbic acid Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults age 18 to 50 years Clinically diagnosed Melasma Irrespective of gender and ethnicity

You may not qualify if:

  • pregnant and lactating women Patients with a history of skin allergies to study medications Use of systemic steroides or anti coagulants within the last month Patients on other melasma treatments for atleast 4 weeks prior

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • aneeqa khan

    Hayatabad Medical Complex

    STUDY CHAIR

Central Study Contacts

Aneeqa Aneeqa Khan, Mbbs

CONTACT

+923409259017aneeqakhan1419@gmail.com

Ayesha Ayesha Naeem, Mbbs

CONTACT

03459133233Ayeshasaddozai976@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor Dermatology unit HMC

Study Record Dates

First Submitted

April 4, 2026

First Posted

April 13, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share