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

• Status: ACTIVE_NOT_RECRUITING
• Trial end date: 2026-03-26

Summary

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.

• Phase: PHASE2

Details

• Lead Sponsor: King Edward Medical University
• Treatments: Glutathione; Tranexamic Acid