Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar

NCT05771623 | Unknown

• 1 other identifier: P.T.REC/012/003749
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertrophic Scar

Keywords

Hypertrophic scar

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• High resoluton ultrasonography

  Change of hypertrophic scar thickness from the beginning of treatment to 6 months after treatment.

• Patient and observer scar assessment scale

  Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 6 months after treatment.

Study Arms (2)

Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar

EXPERIMENTAL

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; Behavioral: Traditional physical therapy

Traditional physical therapy for postburn hypertrophic scar

ACTIVE COMPARATOR

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

Interventions

Iontophoresis drug delivery device 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).

Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar

Traditional physical therapy BEHAVIORAL

Traditional PT: Stretching, deep friction massage and pressure therapy (2 times per week for 3 months).

Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar; Traditional physical therapy for postburn hypertrophic scar

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Giza, Dokki, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

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

Study Officials

• A M Abd Elbaky, Professor

  faculty of physical therapy

  STUDY DIRECTOR

Central Study Contacts

H M Alnawagy, A lecturer

CONTACT

+201032733250; hayammahmoud120@gmail.com

A M Abd El Baky, Professor

CONTACT

+201124663339; amalabaky@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Model Details: Control group: (38 patients with hypertrophic scar) receive traditional PT for postburn scar. Study group: (38 patients with hypertrophic scar) receive botulinum toxin type a iontophoresis plus traditional PT.

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 16, 2023
• Study Start: August 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)