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The current study aimed to evaluate the effectiveness of fractional laser treatment alone and fractional laser combined with botulinum toxin A, delivered either through injections or topical application fractional laser-assisted drug delivery (FLADD) in hypertrophic burn scar
Burn injuries represent a major global health concern, often resulting in long term physical, psychological, and social consequences. Among the most challenging sequelae are hypertrophic scars, which arise from abnormal wound healing characterized by fibroblast hyperactivity, excessive collagen deposition and impaired extracellular matrix remodeling. These scars not only compromise skin pliability and aesthetics but also restrict mobility, leading to functional disability and reduced quality of life.
Traditional management strategies including surgical excision, corticosteroid injections, silicone gel, pressure therapy, and radiation have shown variable efficacy, with high recurrence rates and limited patient satisfaction. In recent years, minimally invasive modalities such as fractional CO2 laser therapy have gained prominence for their ability to remodel scar tissue and improve texture. Concurrently, botulinum toxin type A (BTXA) has emerged as a promising antifibrotic agent, exerting its effects by reducing wound tension, modulating fibroblast activity, and regulating collagen synthesis.
The integration of fractional CO2 laser with BTXA, delivered either intralesionally or via laser assisted drug delivery, offers a novel therapeutic approach aimed at enhancing scar pliability, contour and patient comfort. This study investigates the comparative efficacy of these modalities in the treatment of post burn hypertrophic scars, providing evidence to guide optimized clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Received Fractional CO2 Laser with Intralesional Botox injection (FL + Inj. Botox). | Active Comparator |
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| Received Fractional CO2 Laser Only (FL Only). | Active Comparator | Fractional CO2 laser treatment was performed using ( DEKA SmartXide DOT, Italy). Treatment parameters included power (18-20W), dwell time (800-1000µs), spacing (500-600µm, 13% density), micro spot size (120µm), and 2-3 stacks, adjusted depending on scar height For eye protection, eye goggles were used during the sessions. Patients were instructed to apply a full-spectrum sunscreen regularly. Topical antibiotic cream was applied twice per day for 5 days following the session, and emollients twice daily for two weeks |
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| Received Fractional CO2 Laser with Botulinum Toxin Assisted Drug Delivery (topical) (FL + Topical Bo | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin type A (Botox®, Allergan) | Drug | Fractional CO2 laser 10, 6000nm |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in total Patient and Observer Scar Assessment Scale (POSAS) score for each scar section | The Patient and Observer Scar Assessment Scale (POSAS) include a 6-item Patient Scar Assessment Scale (score range 6-60) and a 5-item Observer Scar Assessment Scale (score range 5-50). Each item is scored from 1 (normal skin) to 10 (worst imaginable scar). Total scores are calculated by summing item scores. The primary endpoint is the change in POSAS total score (patient and observer components) from baseline to 3 months after the last treatment session for each of the three scar sections. | Baseline and 3 months after the last treatment session |
| Change in Vancouver Scar Scale (VSS) total score | The VSS evaluates four scar characteristics: pigmentation (0-2), vascularity (0-3), pliability (0-5), and height (0-3). Total VSS score ranges from 0 to 13, with higher scores indicating more severe scarring. The outcome is the change in total VSS score between baseline and 3 months after the final treatment session. | Baseline and 3 months after the last treatment session. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quantitative scar elevation measured by Antera 3D imaging | •Scar elevation (height above surrounding normal skin) will be measured in microns using the Antera 3D camera (Miravex, Dublin). The same region of interest (ROI) is analyzed at baseline and follow-up using the software's alignment/synchronization feature. The outcome is the change in mean elevation value (µm). | Baseline and 3 months after the last treatment session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marwa Salah El-Mesidy, MD | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Cairo | Cairo Governorate | 02002 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36718819 | Background | Tawfik AA, Ali RA. Evaluation of botulinum toxin type A for treating post burn hypertrophic scars and keloid in children: An intra-patient randomized controlled study. J Cosmet Dermatol. 2023 Apr;22(4):1256-1260. doi: 10.1111/jocd.15634. Epub 2023 Jan 31. | |
| Background | Sabry, H.H., Hamed, A.M., & Ibrahim, E.A. (2020). Comparative Study between Intralesional and Topical Botulinum Toxin A Combined with Fractional Carbon Dioxide Laser in Treatment of Hypertrophic Scars and Keloids (Comparative study). Benha Journal of Applied Sciences, 5(3 part (2)), 187-189. |
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| Change in scar roughness/texture measured by Antera 3D imagingChange in scar roughness/texture measured by Antera 3D imaging | Surface texture irregularity will be quantified using Antera 3D software's roughness parameter, reported in microns. The same ROI is assessed at both visits to measure change in roughness. | Baseline and 3 months after the last treatment session. |
| Change in scar redness (oxyhemoglobin concentration) measured by Antera 3D imaging | Antera 3D hemoglobin analysis quantifies vascularity using hemoglobin level and hemoglobin variation parameters. Results are expressed as numeric values representing vascularity intensity. The endpoint is the change in hemoglobin parameters from baseline. | Baseline and 3 months after the last treatment session. |
| Change in scar pigmentation (melanin concentration) measured by Antera 3D imaging | Melanin level and melanin variation are quantified through Antera 3D imaging. Numeric melanin values are compared between baseline and follow-up to determine improvement in hyperpigmentation. | Baseline and 3 months after the last treatment session |
| Global Assessment Score (Independent Blinded Evaluator) | A single blinded dermatologist will provide a global qualitative rating of scar improvement, integrating texture, vascularity, color, and height. Scores will be reported categorically using a 5-point scale:
| 3 months after the final treatment session |
| ID | Term |
|---|---|
| D017439 | Cicatrix, Hypertrophic |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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