Comparison of Intradermal Microinjections of Tanexamic Acid and Oral Tranexamic Acid in the Management of Melasma.

NCT07280234 | Completed Early Phase 1

• 1 other identifier: HayatabadHMC
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

In this study we compared the effect of intradermal microinjections of tranexamic acid vs oral tranexamic acid in treatment of melasma. Given the high prevalence of melasma in Pakistan and the significant psychosocial impact on patients, particularly in Peshawar, this study will provide valuable insights into optimal treatment strategies

Conditions

Melasma

Keywords

Melasma

Outcome Measures

Primary Outcomes (1)

• Assessment of Melasma Area and Severity Index

  The primary outcome measure was the change in modified Melasma Area and Severity Index (mMASI) scores from baseline to week 8 assessed by the researcher under the direction supervision of a consultant dermatologist with experience of five years or more. The treatment response was assessed using the aforementioned index as Poor response (\< 25%), mild response (25 to 50%), moderate response (51 to 75%) and excellent response (\> 75%). Follow-up visit was scheduled at 8-week interval for clinical evaluation, mMASI scoring and monitoring of treatment adherence.

  Six months

Study Arms (2)

Intradermal microinjections of Tranexamic Acid

ACTIVE COMPARATOR

In this group patients will recieve intradermal microinjections of tranexamic acid

Drug: Intradermal microinjections of tranexamic acid

Oral tranexamic acid

ACTIVE COMPARATOR

In this group patients will recieve oral tranexamic acid

Drug: Oral tranexamic acid

Interventions

Intradermal microinjections of tranexamic acid DRUG

This group A will recieve intradermal microinjections of tranexamic acid

Intradermal microinjections of Tranexamic Acid

Oral tranexamic acid DRUG

This group B will recieve oral tranexamic acid

Oral tranexamic acid

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 55 years, with clinically confirmed melasma of at least 6 months duration.
• Fitzpatrick skin types III-V and no active dermatological conditions in the treatment area.

You may not qualify if:

• pregnancy or lactation
• History of thromboembolic disorders
• Use of hormonal therapies or photosensitizing medications
• Recent melasma treatments within the past 3 months
• Known hypersensitivity to tranexamic acid.

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Study Sites (1)

MTI-HMC Peshawar, Peshawar Khyber Pakhtunkhwa

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Melanosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ghafoor Ullah Ullah, FCPS part 2

  MTI-HMC Peshawar, Peshawar Khyber PakhtunKhwa 25000

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Medical Officer

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 12, 2025
• Study Start: November 14, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

PA (1)