Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar

The goal of this clinical trial study: is to determine the effect Botulinum toxin type A iontophoresis in hypertrophic scars for post burned patients. The main question is it aims to answer is:

• Does Botulinum toxin type A iontophoresis may help in minimizing postburn hypertrophic scars?
• Participants will receive the treatment for 3 months.
• Assessment will be done before and after treatment.

Study Overview

• Status: Recruiting
• Conditions: Hypertrophic Scar
• Intervention / Treatment: Device: Iontophoresis drug delivery device; Behavioral: Traditional physical therapy

Detailed Description

1. Subjects:

   Seventy-six Patients from both genders who have post burn hypertrophic scar will participate in this study. Their ages will be ranged 20 to 40 years.

2. Design of the study:

In this study the patients will be randomly assigned into two equal groups (38 patients for each group):

1. Group A (Study group):

   This group includes 38 patients who will receive botulinum toxin type A iontophoresis once monthly for 3 months, in additional to traditional physical therapy (Positioning, Stretching exercises, Pressure Therapy and Massage) 2 sessions per week for 3 months.

2. Group B (Control group):

   This group includes 38 patients who will receive traditional physical therapy (Positioning, Stretching exercises, Pressure Therapy and Massage) 2 sessions per week for 3 months.

   - Equipments:

   Measurement equipments:

   1. Sonography:

      It is high-resolution B-image sonogram which allows a good penetration depth of up to 40 mm into the skin and a resolution of around 158 micro m. It has been successfully utilized for objectively measuring pathological scars.

   2. Patient and Observer Scar Assessment Scale (POSAS):

      It consists of two parts; one for the patient (Patient scale; POSAS Patient) and one for the physician (Observer scale; POSAS Observer). Both contain six items on a 10-point rating scale and an extra category "Overall Opinion". All characteristic features of the pathological scars are covered by the questionnaire: vascularity, pigmentation disorders, relief/texture, thickness, pliability, surface area, pain, and itching/pruritus. The latter items, in particular, concern the well-being of the patients.

      • Sonography:

        • High frequency ultrasound is the most common used technique for scar assessment.

        • The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure.

        • The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency b. Patient and Observer scar Assessment Scale (POSAS):

        • The scar will be rated numerically on a ten-step scale by both the patient and doctor.

        • Six items on the Observer Scale: vascularity, pigmentation, thickness, relief, pliability, and surface area.

        • The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar.

        • One of the reasons POSAS was chosen for scar evaluation is because it is the only scar assessment tool to include a component for patients to fill in.
        • Furthermore, its distinctive feature of reflecting subjective symptoms like pain and pruritus and because of its appropriateness for everyday practice.
        • Both sonography and POSAS will be used for assessment of hypertrophic scar pre-treatment and post treatment (after 3 months then after 6 months as follow up).
      • Procedures of iontophoresis drug delivery device:

      the iontophoresis group will receive botulinum toxin type A iontophoresis using an iontophoretic drug delivery system (Phoresor IIAuto,Model PM850, IOMED.) - Procedures of botulinum toxin type A iontophoresis:

      • Botulinum toxin type A (Botox Allergan ®, Irvine, CA, USA) will be used.

      • 100 U vacuum-dried powder in a single-use vial for reconstitution diluted in 2 mL of sterile, preservative-free 0.9% saline to constitute a solution at a concentration of 4 U/0.1 mL) will be administered once a month for a total period of three months.

      • The dose will be adjusted to 2.5 U/cm2 of the lesion.

      • The dose shouldn't exceed 100 units per session.

        • Physical therapy program for both groups:

      traditional physical therapy (Positioning, Stretching exercises, Pressure Therapy and Massage) 2 sessions per week for 3 months

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: H M Alnawagy, A lecturer; Phone Number: +201032733250; Email: hayammahmoud120@gmail.com
• Study Contact Backup: Name: A M Abd El Baky, Professor; Phone Number: +201124663339; Email: amalabaky@yahoo.com

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 11432
      • Recruiting
      • Faculty of Physical Therapy
      • Contact: A M Abd Elbaky, Professor; Phone Number: +201124663339; Email: amalabaky@yahoo.com
      • Contact: N H Aboelnour, A. Professor; Phone Number: Telephone: 01068904389

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient with hypertrophic scar (3-6) months after burn healing.
• Age range between 20-40 years.
• Male and female patients will participate in the study.
• All patients have a postburn hypertrophic scar at different body sites.
• All patients enrolled on the study will have their informed consent.

Exclusion Criteria:

• Patients with prior medical histories of cardiac arrhythmias.
• Patients with cardiac pacemakers.
• Patients with orthopedic implants.
• Areas of skin with lesions and impaired sensation.
• During pregnancy and breastfeeding.
• Patient with diabetes mellitus.
• Patients with a history of hypersensitivity or adverse reactions associated with (BTX_A).
• Recent BTA administration 6 months before the study.
• Any subject complaining of psychiatric disorders or neurological disorders such as myasthenia gravis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar; The study group includes 38 postburn hypertrophic scar patients l receiving Botox iontophoresis once monthly for 3 months; in addition to their physical therapy program (Stretching exercises, Pressure Therapy and Massage) 2 sessions per week for 3 months. Botulinum toxin type A (Botox Allergan ®, Irvine, CA, USA) is used. 100 U vacuum-dried powder in a single-use vial for reconstitution diluted in 2 mL of sterile, preservative-free 0.9% saline to constitute a solution at a concentration of 4 U/0.1 mL) is being administered once a month for a total period of three months. The dose will be adjusted to 2.5 U/cm2 of the scar. The dose shouldn't exceed 100 units per session.	Device: Iontophoresis drug delivery device; Botulinum toxin type A (Botox Allergan ®, Irvine, CA, USA) is used. 100 U vacuum-dried powder in a single-use vial for reconstitution diluted in 2mL of sterile, preservative-free 0.9% saline to constitute a solution at a concentration of 4 U/0.1 mL) is being administered once a month for a total period of three months. The dose will be adjusted to 2.5 U/cm2 of the scar. The dose shouldn't exceed 100 units per session. This can be done through the Iontophoresis drug delivery device. Traditional PT: Stretching, deep friction massage and pressure therapy (2 times per week for 3 months).; Behavioral: Traditional physical therapy; Traditional PT: Stretching, deep friction massage and pressure therapy (2 times per week for 3 months).
Active Comparator: Traditional physical therapy for postburn hypertrophic scar; This group includes 38 patients with postburn hypertrophic scar who will receive the traditional PT (deep friction massage, stretching and pressure therapy).	Behavioral: Traditional physical therapy; Traditional PT: Stretching, deep friction massage and pressure therapy (2 times per week for 3 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High resoluton ultrasonography	High frequency ultrasound is the most common used technique for scar assessment. Its inferior resolution compared to optical equivalents is mitigated by its superior penetration depth allowing thickness analysis, even in severe scar thickening. The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure. The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency.	Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment(after 3 months from the beginning of treatment).
Patient and observer scar assessment scale	The scar will be rated numerically on a ten-step scale by both the patient and doctor on six items: vascularity, pigmentation, thickness, relief, pliability, and surface area on the Observer Scale. The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar. Minimal score means good progression and maximum score means the scare is worse.	Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 3 months after treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
High resoluton ultrasonography	High frequency ultrasound is the most common used technique for scar assessment. Its inferior resolution compared to optical equivalents is mitigated by its superior penetration depth allowing thickness analysis, even in severe scar thickening. The working mechanism is based on refection of sound waves of structures with different acoustic impedances and the analysis of the refection time to determine the depth of the structure. The penetration depth ranges from the upper dermal layers to full-thickness skin and subcutaneous structures, depending on the employed frequency.	Change of hypertrophic scar thickness from the beginning of treatment to 6 months after treatment.
Patient and observer scar assessment scale	The scar will be rated numerically on a ten-step scale by both the patient and doctor on six items: vascularity, pigmentation, thickness, relief, pliability, and surface area on the Observer Scale. The Patient Scale consists of pain, itchiness, color, stiffness, thickness, and irregularity of the scar. Minimal score means good progression and maximum score means the scare is worse.	Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 6 months after treatment.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: A M Abd Elbaky, Professor, Faculty of Physical Therapy

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 4, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hypertrophic scar
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Cicatrix; Hypertrophy; Cicatrix, Hypertrophic
• Other Study ID Numbers: P.T.REC/012/003749

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No