- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07420166
Comparison of Intralesional Triamcinolone Acetonide Treatment With Intralesional Verapamil Hydrochloride in Keloids
February 12, 2026 updated by: Muhammad Aamir Latif
Comparison of the Outcome of Treatment of Intralesional Triamcinolone Acetonide With Intralesional Verapamil Hydrochloride in Patients Presenting With Keloid at Tertiary Care Hospital, Bahawalpur.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Although the anti-inflammatory and scar-enhancing properties of corticosteroids on hypertrophic scars and keloids have been investigated and documented thoroughly.
There are many different treatments for keloids nowadays; each method has its advantages and disadvantages, and the results also vary depending on each study.
Moreover, local data to address this issue is also scarce.
The findings of this study would not add to the existing stats, but comparing the outcomes of both the drugs would also guide clinicians towards better management of keloids by choosing the more appropriate treatment.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab Province
-
Bahawalpur, Punjab Province, Pakistan, 63100
- Bahawal Victoria Hospital/Quaid-e-Azam Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Triamcinolone Group
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.
|
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.
|
|
Experimental: Verapamil 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scar assessment
Time Frame: 24 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bakhtawar, Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur
- Study Director: Salman Ashraf, FCPS, Bahawal Victoria Hospital/Quaid-e-Azam Medical College, Bahawalpur
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Actual)
June 30, 2025
Study Completion (Actual)
June 30, 2025
Study Registration Dates
First Submitted
February 12, 2026
First Submitted That Met QC Criteria
February 12, 2026
First Posted (Actual)
February 19, 2026
Study Record Updates
Last Update Posted (Actual)
February 19, 2026
Last Update Submitted That Met QC Criteria
February 12, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Connective Tissue Diseases
- Cicatrix
- Fibrosis
- Collagen Diseases
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Keloid
- Organic Chemicals
- Polycyclic Compounds
- Amines
- Triamcinolone
- Pregnadienes
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Steroids, Fluorinated
- Phenethylamines
- Ethylamines
- Triamcinolone Acetonide
- Verapamil
Other Study ID Numbers
- Dr-Bakhtawar-BVH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data can be shared on a reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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