Treatment of Hypertrophic Scars Using Fractional CO2 Laser Alone in Comparison With Adding Botulinum Toxin Either Through Intralesional Injection or Assisted Drug Delivery

NCT07360483 | Completed DMC

• 1 other identifier: MS-257 2024
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertrophic Scars

Keywords

hypertrophic scar; LADD; botulinum toxin A

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (5)

• Change in quantitative scar elevation measured by Antera 3D imaging

  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

  Baseline and 3 months after the last treatment session.

• Change in scar redness (oxyhemoglobin concentration) measured by Antera 3D imaging

  Baseline and 3 months after the last treatment session.

• Change in scar pigmentation (melanin concentration) measured by Antera 3D imaging

  Baseline and 3 months after the last treatment session

• Global Assessment Score (Independent Blinded Evaluator)

  3 months after the final treatment session

Study Arms (3)

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

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

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

Drug: Botulinum toxin type A (Botox®, Allergan)

Interventions

Botulinum toxin type A (Botox®, Allergan) DRUG

Fractional CO2 laser 10, 6000nm

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).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Cairo Governorate, 02002, Egypt

Location

Related Publications (2)

• 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.

  PMID: 36718819 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.

  BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Marwa Salah El-Mesidy, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 22, 2026
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG (1)