botulinum toxin type a iontophoresis for postburn hypertrophic scar

Conditions: Hypertrophic Scar

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.

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.

Keywords: hypertrophic scar