Comparison of Intralesional Triamcinolone Versus Verapamil for Keloid Treatment

NCT06897969 | Not Yet Recruiting Phase 4

• 1 other identifier: 21467/NMU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Keloid Scars

Keywords

Keloid; Vancouver scar scale; Triamcinolone; Verapamil; Intralesional injection

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Verapamil Treatment

ACTIVE COMPARATOR

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

Triamcinolone Treatment

EXPERIMENTAL

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

Interventions

Triamcinolone Acetonide 1 ml of 40 mg/mL suspension DRUG

Monthly intralesional injection

Triamcinolone Treatment

Verapamil Injection DRUG

2.5 mg of intralesional Verapamil injection monthly

Verapamil Treatment

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nishtar Medical University: lead

Study Sites (1)

Nishtar Medical University & Hospital

Multan, Punjab Province, 60000, Pakistan

Location

Related Publications (3)

• 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.

  PMID: 34278918 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 30775139 BACKGROUND

MeSH Terms

Conditions

Keloid

Interventions

Triamcinolone Acetonide; Suspensions; Verapamil

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Dr. Aliya Akhtar, FCPS

  Nishtar Medical University

  STUDY DIRECTOR

Central Study Contacts

Dr. Asma Batool, MBBS

CONTACT

923470416435; abatool709@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: April 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)