NCT07195539

Brief Summary

It will be a case within control trial. After IRB approval patients presenting with more than 6 months old hyperpigmented burn scars will be included in this study. All data (including age, gender, mode of burn) will be recorded on a proforma and standardized pre-intervention photographs will be taken. The hyperpigmented scar will be divided into two equal halves.One half will receive fractional CO2 wit TXA solution other half will receive fractional CO2 Laser with N/S solution.Thus allocation will be done randomly with the lottery method. Total 3 sessions of LADD will be done with 1 month interval between each session. The following settings will be used: probe frequency 75Hz; Power range 12-15W; dwell time 300 micros-500 micros, stach 1-2 and spacing 900-1200m. The TXN solution will be prepared by mixing 250mg of TXA in 5ml of N/S creating a 5% TXN solution. Standardized photographs will again be taken 3 months after the 3rd session. The pre- and post-treatment photographs will be assessed by Skin Hyperpigmentation Index (SHI) using a smartphone dermatoscope adapter and an online calculator, freely available at: https://shi.skini magea nalys is.com, can be used. 15. Any complications during treatment will be noted and documented. Patient satisfaction wil be measured on a Likert scale of 1-5.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

December 1, 2025

Status Verified

June 1, 2025

Enrollment Period

8 months

First QC Date

September 9, 2025

Last Update Submit

November 23, 2025

Conditions

Keywords

fractional ablative lasertranexamic acidpost burn hyperpigmentation

Outcome Measures

Primary Outcomes (2)

  • improvement in hyperpigmentation

    3 months after completion of sessions

  • hyperpigmentation

    Skin Hyperpigmentation Index will be used to determine improvement in hyperpigmentation.

    3months after completion of sessions

Study Arms (1)

hyperpigmented lesion divided into halves and one for tranexamic acid one for saline

EXPERIMENTAL

this will be a split face study, each lesion will be divided into 2 halves one half will receive tranexamic acid spray while other will receive saline spray. each patient will act as his own control.

Other: Tranexamic Acid sprinkle with CO2 LASER

Interventions

tranexamin acid will be sprayed after CO2 LASER

hyperpigmented lesion divided into halves and one for tranexamic acid one for saline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age more than 18y
  • Hyperpigmented Burn scar presenting after 6 months
  • Patients with burn scar on face, neck, hands

You may not qualify if:

  • Previous laser treatment
  • Coagulation or platelet disorder
  • Patients on anticoagulant medications/birth control pills
  • DM/Connective tissue disorder
  • Active viral infection
  • History of malignancy/chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Schaffrick L, Ding J, Kwan P, Tredget E. The dynamic changes of monocytes and cytokines during wound healing post-burn injury. Cytokine. 2023 Aug;168:156231. doi: 10.1016/j.cyto.2023.156231. Epub 2023 May 27.

    PMID: 37247448BACKGROUND

Related Links

MeSH Terms

Interventions

Lasers, Gas

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: same patient will be receiving both treatments on different parts.each participant act as their own control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Registrar

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 26, 2025

Study Start

June 1, 2025

Primary Completion

January 30, 2026

Study Completion

February 28, 2026

Last Updated

December 1, 2025

Record last verified: 2025-06

Locations