NCT07263841

Comparison of Effectiveness of Tranexamic Acid Mesotherapy Versus Glutathione Mesotherapy in Post Burn Facial Hyperpigmentation

Active, enrolled Phase 2 Last updated 4 December 2025

What this trial tests

Phase 2 trial testing Tranexamic Acid in Post Burn Facial Hyperpigmentation in 60 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2025

Primary endpoint
26 December 2025

26 March 2026

Quick facts

Lead sponsor	King Edward Medical University
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 June 2025
Primary completion	26 December 2025
Estimated completion	26 March 2026
Sites	1 location across Pakistan

Drugs / interventions tested

• Tranexamic Acid (Tranexamic Acid) — full drug profile →

Conditions studied

• Post Burn Facial Hyperpigmentation — all drugs for Post Burn Facial Hyperpigmentation →

Sponsor

King Edward Medical University

Who can join

Adults 18 to 65, any sex, with Post Burn Facial Hyperpigmentation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

INTERVENTION:

Patch test on forearm will be performed in all patients before starting treatment to check the sensitivity. Site of burn in the enrolled patients will include either cheek or forehead and total area (cm2) on each of above mentioned sites will be divided into two equal halves; one for tranexamic acid mesotherapy (maximum 5cm2) and other for glutathione mesotherapy (maximum 5cm2). Flip coin method will be used to decide which site and which half to be treated with tranexamic Acid or glutathione. Gentle cleansing of the affected area will be done Tranexamic acid is available in 500mg/5ml formulation, 1ml (100mg) of tranexamic acid will be taken and diluted in 10ml of 0.9% N/S i.e. 10mg/ml.This 10mg/ml of diluted formulation will be used for mesotherapy.

intradermally 1cm apart to the selected site using 1cc disposable syringe with 4mm depth 30G needle.4mm depth of intradermal injection will be controlled manually by the researcher on specific area of face. Maximum dose of tranexamic acid microinjections will not exceed 12.5 mg/5cm'.

Glutathione is available in 600mg powder formulation and will be prepared by dissolving in 5ml of distilled water. 1ml (120mg) of glutathione will be diluted in 10ml of 0.9% N/S i.e. 12mg/ml.This 12mg/ml of diluted formulation will be used for mesotherapy. Multiple microinjections, each 0.05ml (0.6mg) will be given intradermally 1cm apart to the selected site using 1cc disposable syringe with 4mm depth 30G needle. Maximum dose will not exceed 15mg/5cm2. All patients will be kept under observation for 20-30 minutes after each session to address any side effects (bruising, bleeding, pain etc.) and they will be advised to apply sunscreen of SPF 50 on whole of the face before sun exposure. After initial treatment session, patients will undergo six more treatment sessions with the same protocol at the interval of 2 weeks ( 2, 4, 6, 8, 10,12 weeks) and follow-up will be done monthly after the last session i.e. 4th, 5th and 6th month.

Final assessment will be done at 6th month. All clinical dermatoscopic photographs will be taken with Nikon D810 digital camera with dermlite 3 dermoscopy lens before the start of treatment, at each treatment session and then at each follow-up in same pre-settings, light and from same distance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.