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

NCTNCT07263841Other id435/RC/KEMU

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Overview

Status: Active, not recruiting
Phase: Phase 2
Enrollment: 60 participants (estimated)
Sponsor: King Edward Medical University · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Pakistan
Start: 1 Jun 2025
Primary completion: 26 Dec 2025 (estimated)
Completion: 26 Mar 2026 (estimated)
First posted: 4 Dec 2025
Last update posted: 4 Dec 2025
Conditions: Post Burn Facial Hyperpigmentation

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202520262027

Ph 2
Comparison of Effectiveness of Tranexamic Acid Mesotherapy Versus Glutathione Mesotherapy in Post Burn Facial Hyperpigmentation
NCT07263841
1 Jun 2025 to est. 26 Mar 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Tranexamic AcidDrug

Arms1

Experimental
fitzpatrick skin type3,4 patients of post burn facial hyperpigmentation will be included in this arm
facial hyperpigmentation lesion will be divided into 2 halves and one treatment will be administered on each half

Primary outcomes1

Outcomes the sponsor listed as primary.

improvement in facial hyperpigmentation
Time frame · 6months
Registry description
patients will be assessed for improvement in hyperpigmentation by skin hyperpigmentation index till 6 months after completion of sessions

Posted results

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No results are posted for this trial.

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Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 65 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria:● Both sexes of WHO adult age group 18-65 years . * 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. Exclusion Criteria:● Patients with documented hypersensitivity reactions to either drug or dressing etc. * 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.

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