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Botulinum Toxin Type a Iontophoresis for Postburn Hypertrophic Scar

NCT05771623 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-06-06

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • A M Abd Elbaky, Professor · faculty of physical therapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771623 on ClinicalTrials.gov