Clinical trial NCT05771623: Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar
Official title: Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertrophic Scar
Keywords: Hypertrophic scar
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: High resoluton ultrasonography
timeFrame: Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment(after 3 months from the beginning of treatment).
measure: Patient and observer scar assessment scale
timeFrame: Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 3 months after treatment.
Secondary outcomes:
Other outcomes:
measure: High resoluton ultrasonography
timeFrame: Change of hypertrophic scar thickness from the beginning of treatment to 6 months after treatment.
measure: Patient and observer scar assessment scale
timeFrame: Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 6 months after treatment.
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
state: Dokki
Study officials:
affiliation: faculty of physical therapy
name: A M Abd Elbaky, Professor
role: STUDY_DIRECTOR
References: