Hypertrophic ScarsBTX and LADDNCT07360483
Treatment of Hypertrophic Scars Using Fractional CO2 Laser Alone in Comparison With Adding Botulinum Toxin Either Through Intralesional Injection or Assisted Drug Delivery
A study testing Botulinum toxin type A (Botox®, Allergan) in people with Hypertrophic Scars, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertrophic Scars
- What is being tested?
- Botulinum toxin type A (Botox®, Allergan)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scar Type: Clinically diagnosed hypertrophic burn scar not less than 4.5 cm
- Minimum Scar Size: 4.5cm x 1 cm
- Scar duration: At least 1 month old and not exceed 6 months.
- Fitzpatrick Skin Type: II to IV
- No Recent Scar Treatment: No scar treatment within the past 6 months
- Healthy Skin: No active skin infections in the treatment area
- Normal Neuromuscular Function: No history of neuromuscular disorders or medications affecting muscle function.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Hypertrophic Scars
- Being tested
- Botulinum toxin type A (Botox®, Allergan)
- Keywords
- hypertrophic scar, LADD, botulinum toxin A
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A (Botox®, Allergan)Drug
Fractional CO2 laser 10, 6000nm
| Study group | Role | What they receive |
|---|---|---|
| Received Fractional CO2 Laser with Intralesional Botox injection (FL + Inj. Botox). | Active comparator | * 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
* Immediately following laser treatment, Botulinum toxin type A (Botox Allergan, Irvine, CA; 100U vacuum-dried powder reconstituted in 2mL of sterile, preservative-free 0.9% saline to a concentration of 5U/0.1mL) was injected intralesionally into the scar tissue for Section 1.
* A 24-gauge needle (0.3mm × 0.8mm) was used, and the injection was continued until slight blanching was visible. The dose was adjusted to 2.5 U/cm³ of the lesion, not exceeding 100 units per session Receives: Drug: Botulinum toxin type A (Botox®, Allergan) |
| 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 Receives: Drug: Botulinum toxin type A (Botox®, Allergan) |
| Received Fractional CO2 Laser with Botulinum Toxin Assisted Drug Delivery (topical) (FL + Topical Bo | 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 (Tawfic et al., 2022). 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.
* Immediately following laser treatment, Botulinum toxin type A (Botox Allergan, Irvine, CA; 100U vacuum-dried powder reconstituted in 2mL of sterile, preservative-free 0.9% saline to a concentration of 5U/0.1mL) -• Immediately following laser treatment for Section 3, topical Botulinum toxin (prepared at the same concentration 2.5 U/cm³ of the lesion as for intralesional injection and adjusted to 2.5 U/cm³) was applied to the treated area topically Receives: Drug: Botulinum toxin type A (Botox®, Allergan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 3 months after the last treatment session.
Secondary outcomes (5)
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).
Measured: Baseline and 3 months after the last treatment session
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.
Measured: 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.
Measured: 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.
Measured: 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:
- = No improvement,
- = Mild,
- = Moderate,
- = Marked,
- = Excellent improvement.
Measured: 3 months after the final treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Jan 2025
- Primary completion1 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic ScarsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Fahim, Cairo University
- Investigators
- Marwa Salah El-Mesidy, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360483
- Sponsor's protocol ID
- MS-257 2024
- Acronym
- BTX and LADD
- Status last verified
- Jan 2026
- First submitted
- 27 Dec 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 36718819Sabry, 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hypertrophic Scars Using Fractional CO2 Laser Alone in Comparison With Adding Botulinum Toxin Either Through Intralesional Injection or Assisted Drug Delivery
- ClinicalTrials.gov ID
- NCT07360483
- Acronym / sponsor ID
- BTX and LADD / MS-257 2024
- Conditions
- Hypertrophic Scars
- Keywords
- hypertrophic scar, LADD, botulinum toxin A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Received Fractional CO2 Laser with Intralesional Botox injection (FL + Inj. Botox). | Active comparator | Drug: Botulinum toxin type A (Botox®, Allergan)* 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 * Immediately following laser treatment, Botulinum toxin type A (Botox Allergan, Irvine, CA; 100U vacuum-dried powder reconstituted in 2mL of sterile, preservative-free 0.9% saline to a concentration of 5U/0.1mL) was injected intralesionally into the scar tissue for Section 1. * A 24-gauge needle (0.3mm × 0.8mm) was used, and the injection was continued until slight blanching was visible. The dose was adjusted to 2.5 U/cm³ of the lesion, not exceeding 100 units per session |
| Received Fractional CO2 Laser Only (FL Only). | Active comparator | Drug: Botulinum toxin type A (Botox®, Allergan)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 |
| Received Fractional CO2 Laser with Botulinum Toxin Assisted Drug Delivery (topical) (FL + Topical Bo | Active comparator | Drug: Botulinum toxin type A (Botox®, Allergan)* 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 (Tawfic et al., 2022). 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. * Immediately following laser treatment, Botulinum toxin type A (Botox Allergan, Irvine, CA; 100U vacuum-dried powder reconstituted in 2mL of sterile, preservative-free 0.9% saline to a concentration of 5U/0.1mL) -• Immediately following laser treatment for Section 3, topical Botulinum toxin (prepared at the same concentration 2.5 U/cm³ of the lesion as for intralesional injection and adjusted to 2.5 U/cm³) was applied to the treated area topically |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Scar Type: Clinically diagnosed hypertrophic burn scar not less than 4.5 cm
- Minimum Scar Size: 4.5cm x 1 cm
- Scar duration: At least 1 month old and not exceed 6 months.
- Fitzpatrick Skin Type: II to IV
- No Recent Scar Treatment: No scar treatment within the past 6 months
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A (Botox®, Allergan)Fractional CO2 laser 10, 6000nm | Drug | Received Fractional CO2 Laser Only (FL Only)., Received Fractional CO2 Laser with Botulinum Toxin Assisted Drug Delivery (topical) (FL + Topical Bo, Received Fractional CO2 Laser with Intralesional Botox injection (FL + Inj. Botox). |
Primary outcome
Change in total Patient and Observer Scar Assessment Scale (POSAS) score for each scar section
Time frame: 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
Time frame: 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.
5 secondary outcomes
Change in quantitative scar elevation measured by Antera 3D imaging
Time frame: Baseline and 3 months after the last treatment session
Change in scar roughness/texture measured by Antera 3D imagingChange in scar roughness/texture measured by Antera 3D imaging
Time frame: Baseline and 3 months after the last treatment session.
Change in scar redness (oxyhemoglobin concentration) measured by Antera 3D imaging
Time frame: Baseline and 3 months after the last treatment session.
Change in scar pigmentation (melanin concentration) measured by Antera 3D imaging
Time frame: Baseline and 3 months after the last treatment session
Global Assessment Score (Independent Blinded Evaluator)
Time frame: 3 months after the final treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Background: PubMed 36718819Tawfik 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.
- BackgroundSabry, 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.
- Individual participant dataSharing planned: Yes
Related trials for Hypertrophic Scars
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruitingPhase 2
Phase II Clinical Study on Preliminary Efficacy and Safety of ETD-001 Gel for Hypertrophic Scars
Hypertrophic Scars
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
Recruiting
Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color
Acne Scars - Mixed Atrophic and Hypertrophic, Hyperpigmentation
Recruiting
AVAVA MIRIA General Use
Acne, Acne Scars - Mixed Atrophic and Hypertrophic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa Salah El-Mesidy, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A (Botox®, Allergan) in people with Hypertrophic Scars, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total Patient and Observer Scar Assessment Scale (POSAS) score for each scar section (time frame: Baseline and 3 months after the last treatment session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07360483, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.