Comparison of Intralesional Triamcinolone Versus Verapamil for Keloid Treatment

NCT06897969 — Phase 4, Not yet recruiting, 60 participants, Nishtar Medical University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06897969
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Estimated)
Sponsor	Nishtar Medical University (Other)
Conditions	Keloid Scars
Interventions	Triamcinolone Acetonide 1 ml of 40 mg/mL suspension, Verapamil Injection (Drug)
Dates	start 2025-04-01 (estimated), primary completion 2025-09-30 (estimated), completion 2025-09-30 (estimated), first posted 2025-03-27, last updated 2025-04-01
Locations	1 site in Pakistan

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Verapamil Treatment	Active comparator	Drug: Verapamil Injection	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.
Triamcinolone Treatment	Experimental	Drug: Triamcinolone Acetonide 1 ml of 40 mg/mL suspension	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.

Triamcinolone Acetonide 1 ml of 40 mg/mL suspension (Drug): Monthly intralesional injection
Verapamil Injection (Drug): 2.5 mg of intralesional Verapamil injection monthly

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 10 Years to 50 Years

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

+Locations (1)

Facility	City	Country	Status
Nishtar Medical University & Hospital	Multan, Punjab Province	Pakistan

+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. PMID 34278918
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. PMID 30775139

+Investigators

Dr. Aliya Akhtar, FCPS, Study director, Nishtar Medical University