CO2 FRACTIONAL LASER WITH TRANEXAMIC ACID AS AN EFFECTIVE TOOL FOR POST BURN HYPERPIGMENTATION.
- Conditions
- Post Burn Hyperpigmentation
- Registration Number
- NCT07195539
- Lead Sponsor
- King Edward Medical University
- 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.
- Detailed Description
TITLE:
CO2 FRACTIONAL LASER WITH TRANEXAMIC ACID AS AN EFFECTIVE TOOL FOR POST BURN HYPERPIGMENTATION.
INTRODUCTION Hyperpigmentation is one of the most common sequelae of burns and is due to dysregulation of normal wound healing after burn injury to skin1,2. The proinflammatory cytokine response after a burn stimulates melanocyte proliferation causing increased melanogenesis3. Patients with darker skin are more likely to have hyperpigmented scars. These cosmetically unappealing scars are even more concerning when they involve visible areas of the body, such as the face and hands.
Nonsurgical interventions to prevent or reduce hyperpigmentation of burn scars includes UV protection, hydroquinone application, silicone gel/sheet, nanofat grafting, cryotherapy, and laser and light therapy4. It has also been demonstrated that the earlier the intervention, the better the outcomes are likely to be.
Laser therapy has emerged as a minimally invasive intervention with short post-operative recovery5. Lasers are broadly categorized as ablative or non-ablative, and fractional or non-fractional. Ablative lasers such as the carbon-dioxide (CO2) and Erbium: Yag lasers are generally more effective, but pose a risk of adverse events such as infection, scarring and worsening of pigmentation6. Fractional photo-thermolysis, first described in 2004, leaves columns of non-treated areas between treated columns, thus allowing better wound healing7. Therefore, fractional lasers balance the efficacy of ablative lasers and the safety of non-ablative lasers. Fractional CO2 laser serves to increase dermal pliability, improve abnormal texture, reduce thickness and rehabilitate mature old scars8. A meta-analysis by Zhang et al demonstrated that fractional CO2 laser improved the appearance and pigmentation of post burn scars9.
Tranexamic acid (TXA) is a synthetic amino-acid derivative with hemostatic and anti-inflammatory properties. It works to decrease pigmentation through two mechanisms. Firstly, it reduces inflammatory melanogenesis by inhibiting the conversion of plasminogen to plasmin. Secondly, its causes activation of phagocytosis, leading to degradation of melanogenic enzymes10,11. It is in widespread use in the treatment of hyperpigmentation of melasma12.
Furthermore, laser-assisted drug delivery (LADD) techniques are gaining popularity. Fractional lasers create micro-columns that allows the drug to penetrate into the deeper dermis, and enhances the absorption of topically applied medication13.
The synergistic action of these individual treatments will have favorable outcomes in improving hyperpigmentation in burn scars14. Though there exists data to support this, there is a paucity of literature that specifically studies this effect in the South Asian population with Fitzpatrick skin types 3 and 4 OBJECTIVE; To compare the effects Laser assisted drug delivery of tranexamic acid, versus CO2 laser alone, in treating post burn hyperpigmentation in South Asian skin (Fitzpatrick type 3\&4)
OPERATIONAL DEFINITION; POST BURN HYPERPIGMENTATION; Hyperpigmentation of skin after burn injury, it is more severe in dark-skinned individuals (Fitzpatrick III-VI) ABLATIVE LASER; Any laser that removes skin cells is known as ablative laser. FRACTIONAL LASER; It is a type of laser that targets a portion of skin at a time, leaving normal columns of skin
HYPOTHESIS: Fractional CO2 Laser assisted drug delivery of tranexamic acid will improve post burn hyperpigmentation to a greater degree than Laser alone in South Asian skin (Fitzpatrick III-IV).
SAMPLE SIZE:
Total of 30 patients will be enrolled. A p-value \< 0.05 will be considered statistically significant.
Based on previous findings using the Skin Hyperpigmentation Index (SHI) in melasma patients (Heidemeyer et al., 2023), the estimated standard deviation of SHI scores is approximately 0.52. Assuming a mean difference of 0.5 units between treatment sides in a split-face design, and using a two-tailed paired t-test with 90% power and α = 0.05, a minimum of 19 participants is required to detect a statistically significant difference.
MATERIAL AND METHODS:
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.
Inclusion Criteria:
* Managed conservatively and healed within 3-4 weeks
* Age more than 18y
* Hyperpigmented Burn scar presenting after 6 months
* Patients with burn scar on face, neck, hands
Exclusion Criteria:
* Pregnant and breast feeding women
* 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.
Data Analysis All data will be entered and analyzed using IBM SPSS (IBM Corp., Armonk, N.Y.) version 22.0. quantitative variables such as age will be given as mean. The qualitative variables such as gender, scar improvement and patient satisfaction will be calculated as frequency or percentage. Two tailed pair-t test will be used to compare the scar improvement between the two groups as well as compare scar improvement beween the genders and different age groups.
References
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: 37247448.
2. Hall C, Hardin C, Corkins CJ, Jiwani AZ, Fletcher J, Carlsson A, Chan R. Pathophysiologic Mechanisms and Current Treatments for Cutaneous Sequelae of Burn Wounds. Compr Physiol. 2017 Dec 12;8(1):371-405. doi: 10.1002/cphy.c170016. PMID: 29357133.
3. Taylor S, Grimes P, Lim J, Im S, Lui H. Postinflammatory hyperpigmentation. J Cutan Med Surg. 2009 Jul-Aug;13(4):183-91. doi: 10.2310/7750.2009.08077. PMID: 19706225.
4. Lupon E, Laloze J, Chaput B, Girard P, Cetrulo CL, Lantieri LA, Grolleau JL, Camuzard O, Lellouch AG. Treatment of hyperpigmentation after burn: A literature review. Burns. 2022 Aug;48(5):1055-1068. doi: 10.1016/j.burns.2022.04.017. Epub 2022 Apr 25. PMID: 35537921.
5. Klifto KM, Asif M, Hultman CS. Laser management of hypertrophic burn scars: a comprehensive review. Burns Trauma. 2020 Jan 16;8:tkz002. doi: 10.1093/burnst/tkz002. PMID: 32346540; PMCID: PMC7175764.
6. Brightman LA, Brauer JA, Anolik R, Weiss E, Karen J, Chapas A, Hale E, Bernstein L, Geronemus RG. Ablative and fractional ablative lasers. Dermatologic clinics. 2009 Oct 1;27(4):479-89.
7. Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8. PMID: 19787413.
8. Yumeen S, Khan T. Laser Carbon Dioxide Resurfacing. 2023 Apr 23. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. PMID: 32809379.
9. Zhang C, Yin K, Shen YM. Efficacy of fractional carbon dioxide laser therapy for burn scars: a meta-analysis. J Dermatolog Treat. 2021 Nov;32(7):845-850. doi: 10.1080/09546634.2019.1704679. Epub 2019 Dec 22. PMID: 31865824.
10. Maeda K. Mechanism of action of topical tranexamic acid in the treatment of melasma and sun-induced skin hyperpigmentation. Cosmetics. 2022 Oct;9(5):108.
11. Cho YH, Park JE, Lim DS, Lee JS. Tranexamic acid inhibits melanogenesis by activating the autophagy system in cultured melanoma cells. J Dermatol Sci. 2017 Oct;88(1):96-102. doi: 10.1016/j.jdermsci.2017.05.019. Epub 2017 Jun 7. PMID: 28669590.
12. Taraz M, Niknam S, Ehsani AH. Tranexamic acid in treatment of melasma: A comprehensive review of clinical studies. Dermatol Ther. 2017 May;30(3). doi: 10.1111/dth.12465. Epub 2017 Jan 30. PMID: 28133910.
13. Hsiao CY, Yang SC, Alalaiwe A, Fang JY. Laser ablation and topical drug delivery: a review of recent advances. Expert Opin Drug Deliv. 2019 Sep;16(9):937-952. doi: 10.1080/17425247.2019.1649655. Epub 2019 Aug 7. PMID: 31389261.
14. Huang CY, Lin CH, Tsai YJ, Lin KC, Kuo SC, Wong LS, Lin HP, Hsieh CH. Evaluating the efficacy of combining fractional CO2 laser and topical tranexamic acid for burn scar and hyperpigmentation treatment: A prospective, randomized, single-blinded, split-body study. Dermatologica Sinica. 2024 Oct 1;42(4):265-72.
15. Kristine Heidemeyer, Simone Cazzaniga, Laurence Feldmeyer, Valentina Imstep, Maurice Adatto, Matthias Lehmann, Anna Rammlmair, Lorenzo Pelloni, S. Morteza Seyed Jafari, Simon Bossart MD Skin hyperpigmentation index in melasma: A complementary method to classic scoring systems.1 June 2023 DOI: 10.1111/jocd
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
• Managed conservatively and healed within 3-4 weeks
- Age more than 18y
- Hyperpigmented Burn scar presenting after 6 months
- Patients with burn scar on face, neck, hands
• Pregnant and breast feeding women
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method improvement in hyperpigmentation 3 months after completion of sessions hyperpigmentation 3months after completion of sessions Skin Hyperpigmentation Index will be used to determine improvement in hyperpigmentation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
King Edward Medical University
🇵🇰Lahore, Punjab Province, Pakistan
King Edward Medical University🇵🇰Lahore, Punjab Province, Pakistan