RecruitingPhase 4ACTRN12625000568415

A clinical trial to compare efficacy of intralesional triamcinolone vs intralesional verapamil in patients with keloids/ hypertrophic scars.

Comparison of efficacy of intralesional triamcinolone vs intralesional verapamil in treatment of keloids in patients with keloids/hypertrophic scars.


Sponsor

Noor ul Huda working as resident in khyber teaching hospital Peshawar.

Enrollment

174 participants

Start Date

Dec 1, 2024

Study Type

Interventional

Conditions

Summary

The objective of study is to establish efficacy and complications of intralesional verapamil for the treatment of keloids and hypertrophic scars. We included a total of 174 patients of more than 18 years of age with no history of congestive cardiac diseases. They were divided into group A, who received intralesional verapamil and group B who received triamcinolone. Total of 2 injections were given at monthly interval.. Patients were assessed at the beginning and then after 2 months after the treatment. efficacy was assessed using vancouver scar scale. efficacy will be labelled as positive if total score reduction 75% or more.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Keloids and hypertrophic scars are raised, thickened areas of scar tissue that can form after skin injuries, surgery, or even minor cuts. They can be itchy, painful, and cause significant distress — especially when they appear on visible areas of the body. Currently, steroid injections (triamcinolone) are the most common treatment, but they have side effects including skin thinning. This study is comparing triamcinolone injections with verapamil injections — a calcium channel blocker usually used for heart conditions — as an alternative treatment. Both treatments are given as a series of injections directly into the scar. The study assesses improvement using the Vancouver Scar Scale, a validated scoring tool for scar appearance, texture, and sensation. You may be eligible if you are aged 18–60, have keloid or hypertrophic scars, and do not have congestive heart disease, pregnancy, acromegaly, or a family history of keloids. Both men and women are eligible for this study.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Group A will be recieving intralesional verapamil injection 1ml(2.5mg) every month upto 2 months using 1ml subcutaneous syringe.Efficacy will be determined after 2 months of treatment. The injections

Group A will be recieving intralesional verapamil injection 1ml(2.5mg) every month upto 2 months using 1ml subcutaneous syringe.Efficacy will be determined after 2 months of treatment. The injections will be administered by a registered nurse. The strategies that will be used to assess adherence to the intervention will be the use of same brand verapamil injection using sterile 1ml subcutaneous syringe & needle throughout the duration of study which will be strictly administered by a registered nurse who will be dedicated to this specific task under supervision .


Locations(1)

khyber pakhtunkhwa, Pakistan

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ACTRN12625000568415