NCT07420166

Brief Summary

The paucity of local literature regarding the comparison of intralesional verapamil with intralesional triamcinolone acetonide led this study to be carried out with the objective of comparing the clinical effectiveness of intralesional triamcinolone acetonide and intralesional verapamil hydrochloride in patients with keloids.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 12, 2026

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Scar assessment

    Using the Vancouver Scar Scale, height, vascularity, pliability, and pigmentation were assessed at baseline and compared with post-treatment measures at 24 weeks. A score closer to 0 was deemed as better vascularity (not red), low pigmentation, high pliability (soft), and low thickness.

    24 weeks

Study Arms (2)

Triamcinolone Group

EXPERIMENTAL

Patients received intralesional triamcinolone acetonide (20 mg/mL) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.

Drug: Triamcinolone Acetonide

Verapamil Group

EXPERIMENTAL

Patients were managed with intralesional verapamil hydrochloride (2.5 mg/ml) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.

Drug: Verapamil Hydrochloride

Interventions

Patients received intralesional triamcinolone acetonide (20 mg/ml) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.

Triamcinolone Group

Patients were managed with intralesional verapamil hydrochloride (2.5 mg/ml) at a volume not exceeding 1.5 cc per session every three weeks, for a maximum of eight sessions or until complete scar flattening. Each injection session was preceded by 20 seconds of cryotherapy using cryospray applied at a distance of one centimeter from the lesion.

Verapamil Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Either gender
  • Aged between 20 and 60 years
  • With keloids
  • Benign dermal growths
  • Scar length not exceeding 5 centimeters
  • Keloid duration of five years or less
  • A baseline Vancouver Scar Scale score of 5 or more

You may not qualify if:

  • Pregnant or lactating women
  • A family history of keloids
  • Diagnosed with conditions such as acromegaly, diabetes mellitus, or congestive cardiac disease
  • a history of thyroidectomy
  • Current or recent use of isotretinoin or anabolic steroids, as determined by history, physical examination, blood glucose analysis, and electrocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahawal Victoria Hospital/Quaid-e-Azam Medical College

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Keloid

Interventions

Triamcinolone AcetonideVerapamil

Condition Hierarchy (Ancestors)

Collagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Bakhtawar

    Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur

    PRINCIPAL INVESTIGATOR
  • Salman Ashraf, FCPS

    Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Consultant

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

January 1, 2025

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Data can be shared on a reasonable request.

Locations