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

NCT07263841 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 435/RC/KEMU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post Burn Facial Hyperpigmentation

Keywords

hyperpigmentation; Mesotherapy; Effectiveness

Outcome Measures

Primary Outcomes (1)

• improvement in facial hyperpigmentation

  patients will be assessed for improvement in hyperpigmentation by skin hyperpigmentation index till 6 months after completion of sessions

  6months

Study Arms (1)

fitzpatrick skin type3,4 patients of post burn facial hyperpigmentation will be included in this arm

EXPERIMENTAL

facial hyperpigmentation lesion will be divided into 2 halves and one treatment will be administered on each half

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

tranexamic acid decreases melanogenesis by inhibiting tyrosinase enzyme while glutathione converts eumelanin to pheomelanin

Also known as: glutathione

fitzpatrick skin type3,4 patients of post burn facial hyperpigmentation will be included in this arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with healed facial burns managed conservatively without skin grafting.
• From 6 month to 12 month post burn injury (patient enrollment to be done before scar maturation starts)
• Patients with Fitzpatrick skin types III to IV.
• Patients with mental capacity to give informed consent.

You may not qualify if:

• History of de-pigmentation treatment, phototherapy.
• Healed burn wounds with hypertrophic scar.
• History of bleeding or clotting disorders, renal disease, collagen vascular disease and other photodermatoses3.
• Pregnant or lactating females3.
• Patients on hormone replacement therapy, oral contraceptives, concomitant use of anticoagulant, or any photosensitizing drug3.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Isseroff RR, Rifkin DB. Plasminogen is present in the basal layer of the epidermis. J Invest Dermatol. 1983 Apr;80(4):297-9. doi: 10.1111/1523-1747.ep12534677.

  PMID: 6339645 BACKGROUND

MeSH Terms

Conditions

Hyperpigmentation

Interventions

Tranexamic Acid; Glutathione

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Assistant Professor Plastic surgery, MBBS, FCPS Plastic Surgery, MD

  Mayo Hospital,KEMU,Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: outcome assessor will be masked to overcome biasness
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: each patient will be given both treatments, every participant will act as his own control.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: June 1, 2025
• Primary Completion: December 26, 2025
• Study Completion: March 26, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)