CO2 Fractional Laser With Tranexamic Acid As An Effective Tool For Post Burn Hyperpigmentation.
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 9, 2025
CompletedFirst Posted
Study publicly available on registry
September 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedDecember 1, 2025
June 1, 2025
8 months
September 9, 2025
November 23, 2025
Conditions
Keywords
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
EXPERIMENTALthis 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.
Interventions
tranexamin acid will be sprayed after CO2 LASER
Eligibility Criteria
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
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
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- 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