Hypertrophic Scars
Conditions
Keywords
hypertrophic scar, LADD, botulinum toxin A
Brief summary
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
Detailed description
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.
Interventions
Fractional CO2 laser 10, 6000nm
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Scar Type: Clinically diagnosed hypertrophic burn scar not less than 4.5 cm 2. Minimum Scar Size: 4.5cm x 1 cm 3. Scar duration: At least 1 month old and not exceed 6 months. 4. Fitzpatrick Skin Type: II to IV 5. No Recent Scar Treatment: No scar treatment within the past 6 months 6. Healthy Skin: No active skin infections in the treatment area 7. Normal Neuromuscular Function: No history of neuromuscular disorders or medications affecting muscle function.
Exclusion criteria
* 1\) Pregnancy /Lactation: Pregnant, lactating, or planning pregnancy within 6 months 2) patients did previous intervention for the scar for the last 6 months 3) Bleeding Disorders: Known cases of bleeding disorders 4) patients with allergic reaction to botulinum toxin or with neuromuscular junction diseases (eg, myasthenia gravis) 5) patients on medication that decrease neuromuscular transmission (eg, aminoglycosides, penicillamine, quinine, and calcium channel blockers).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total Patient and Observer Scar Assessment Scale (POSAS) score for each scar section | Baseline and 3 months after the last treatment session | 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. |
| Change in Vancouver Scar Scale (VSS) total score | Baseline and 3 months after the last treatment session. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in scar roughness/texture measured by Antera 3D imagingChange in scar roughness/texture measured by Antera 3D imaging | Baseline and 3 months after the last treatment session. | 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. |
| Change in scar redness (oxyhemoglobin concentration) measured by Antera 3D imaging | Baseline and 3 months after the last treatment session. | 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. |
| Global Assessment Score (Independent Blinded Evaluator) | 3 months after the final treatment session | 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: 1. = No improvement, 2. = Mild, 3. = Moderate, 4. = Marked, 5. = Excellent improvement. |
| Change in quantitative scar elevation measured by Antera 3D imaging | Baseline and 3 months after the last treatment session | •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). |
| Change in scar pigmentation (melanin concentration) measured by Antera 3D imaging | Baseline and 3 months after the last treatment session | 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. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMarwa Salah El-Mesidy, MD
Cairo University
Outcome results
None listed