Comparison of Intralesional Triamcinolone Versus Verapamil for Keloid Treatment

Comparison of Intralesional Triamcinolone and Intralesional Verapamil in the Treatment of Keloids

This study aims to compare the efficacy of intralesional triamcinolone and verapamil in patients presenting with keloid at our local setting. The results will guide us towards better management of keloids by choosing the more appropriate treatment. Adequate treatment will reduce significant emotional and physical distress in patients. We hypothesized that mean reduction in Vancouver Scar Score is higher in triamcinolone acetonide group compared to verapamil after three months of treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Keloid Scars
• Intervention / Treatment: Drug: Verapamil Injection; Drug: Triamcinolone Acetonide 1 ml of 40 mg/mL suspension

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Dr. Asma Batool, MBBS; Phone Number: 923470416435; Email: abatool709@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Multan, Punjab, Pakistan, 60000
      • Nishtar Medical University & Hospital
      • Contact: Dr. Asma Batool, MBBS; Phone Number: 0923470416435; Email: abatool709@gmail.com
      • Principal Investigator: Dr. Asma Batool, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• size of keloid1-5 cm,
• on any site of the body,
• duration less then five years and
• baseline Vancouver scar score of more the or equal to 5

Exclusion Criteria:

• Pregnant or lactating women,
• family history of keloids,
• acromegaly, and
• congestive cardiac diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Verapamil Treatment; One ml (2.5 mg) of Intralesional Verapamil Injection will be administered monthly. The injections will be administered with an insulin syringe of 27-gauge needle. Administration of the treatment medication will be continued till the keloid is flattened or TOTAL DURATION of three months.	Drug: Verapamil Injection; 2.5 mg of intralesional Verapamil injection monthly
Experimental: Triamcinolone Treatment; Intralesional Triamcinolone acetonide (40mg) will be administered monthly. The injections will be administered with an insulin syringe of 27-gauge needle. Administration of the treatment medication will be continued till the keloid is flattened or TOTAL DURATION of three months.	Drug: Triamcinolone Acetonide 1 ml of 40 mg/mL suspension; Monthly intralesional injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vancouver Scar Score	The Vancouver Scar scale assesses four parameters of vascularity, pigmentation, pliability and height. The total score ranges from 0 - 13.	Vancouver Scar score will be measured at baseline (before treatment assignment) and then 4-weeks after completion of treatment - 16-weeks after randomization.

Collaborators and Investigators

• Sponsor: Nishtar Medical University
• Investigators: Study Director: Dr. Aliya Akhtar, FCPS, Nishtar Medical University

Publications and helpful links

General Publications

• Kuang J, An P, Li W. Comparative efficacy and safety of verapamil and triamcinolone in keloid and hypertrophic scar treatment: a meta-analysis. J Cosmet Laser Ther. 2021 Feb 17;23(1-2):26-34. doi: 10.1080/14764172.2021.1950765. Epub 2021 Jul 18.
• Uzair M, Butt G, Khurshid K, Pal SS. Comparison of intralesional triamcinolone and intralesional verapamil in the treatment of keloids. Our Dermatol Online. 2015;6(3):280-4.
• Saki N, Mokhtari R, Nozari F. Comparing the Efficacy of Intralesional Triamcinolone Acetonide With Verapamil in Treatment of Keloids: A Randomized Controlled Trial. Dermatol Pract Concept. 2019 Jan 31;9(1):4-9. doi: 10.5826/dpc.0901a02. eCollection 2019 Jan.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Triamcinolone; Keloid; Verapamil; Intralesional injection; Vancouver scar scale
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Cicatrix; Fibrosis; Collagen Diseases; Keloid; Calcium-Regulating Hormones and Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Enzyme Inhibitors; Anti-Arrhythmia Agents; Membrane Transport Modulators; Calcium Channel Blockers; Vasodilator Agents; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Verapamil
• Other Study ID Numbers: 21467/NMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared to protect patient confidentiality and comply with ethical and regulatory guidelines. Additionally, the study design does not include provisions for public data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No