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Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar

Primary Purpose

Hypertrophic Scar

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Iontophoresis drug delivery device
Traditional physical therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scar focused on measuring Hypertrophic scar

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of physical therapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar

Traditional physical therapy for postburn hypertrophic scar

Arm Description

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.

This group includes 38 patients with postburn hypertrophic scar who will receive the traditional PT (deep friction massage, stretching and pressure therapy).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
June 4, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05771623
Brief Title
Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar
Official Title
Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scar
Keywords
Hypertrophic scar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional physical therapy for postburn hypertrophic scar
Arm Type
Active Comparator
Arm Description
This group includes 38 patients with postburn hypertrophic scar who will receive the traditional PT (deep friction massage, stretching and pressure therapy).
Intervention Type
Device
Intervention Name(s)
Iontophoresis drug delivery device
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Traditional physical therapy
Intervention Description
Traditional PT: Stretching, deep friction massage and pressure therapy (2 times per week for 3 months).
Primary Outcome Measure Information:
Title
High resoluton ultrasonography
Description
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.
Time Frame
Change of hypertrophic scar thickness from the beginning of treatment to the end of treatment(after 3 months from the beginning of treatment).
Title
Patient and observer scar assessment scale
Description
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.
Time Frame
Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 3 months after treatment.
Other Pre-specified Outcome Measures:
Title
High resoluton ultrasonography
Description
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.
Time Frame
Change of hypertrophic scar thickness from the beginning of treatment to 6 months after treatment.
Title
Patient and observer scar assessment scale
Description
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.
Time Frame
Assessing the change of patient and observer scar assessment scale score from baseline (beginning of treatment) to 6 months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
H M Alnawagy, A lecturer
Phone
+201032733250
Email
hayammahmoud120@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
A M Abd El Baky, Professor
Phone
+201124663339
Email
amalabaky@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A M Abd Elbaky, Professor
Organizational Affiliation
faculty of physical therapy
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of physical therapy
City
Giza
State/Province
Dokki
ZIP/Postal Code
11432
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A M Abd Elbaky, Professor
Phone
+201124663339
Email
amalabaky@yahoo.com
First Name & Middle Initial & Last Name & Degree
N H Aboelnour, A. Professor
Phone
Telephone: 01068904389

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar

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