Suspended

Intralesional Botulinum Toxin A and Triamcinolone Acetonide for Keloid Treatment

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What is being tested

Botulinum toxin A

+ Triamcinolone Acetonide

Drug
Who is being recruted

Cicatrix+5

+ Collagen Diseases

+ Connective Tissue Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorUniversitas Padjadjaran
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2024

Actual date on which the first participant was enrolled.

This study focuses on finding the best treatment for keloid scars using two types of injections: Botulinum Toxin A and Triamcinolone Acetonide. Keloids are raised scars that can be itchy or painful and may cause cosmetic concerns. This research is important because it compares the effectiveness of these two treatments in reducing the size and severity of keloids, which can help improve the quality of life for those affected. The study takes place in Indonesia and uses detailed measurements and scales to assess changes in the keloids after treatment, something not done before in this region. Participants in this study receive one of the two treatments directly into their keloid scars through an injection. These treatments are given randomly to ensure unbiased results. The study measures the success of the treatment by looking at changes in the scar's size, blood flow, stiffness, and appearance using specialized equipment like high-resolution ultrasonography. Additionally, photographs and various measurements are taken before and after treatment to document any changes. This careful evaluation aims to determine which injection is more effective in treating keloid scars.

Official TitleThe Effectiveness of Intralesional Botulinum Toxin A and Triamcinolone Acetonide Injections in Keloid Treatment
NCT06814288
Principal SponsorUniversitas Padjadjaran
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CicatrixCollagen DiseasesConnective Tissue DiseasesFibrosisKeloidPathologic ProcessesPathological Conditions, Signs and SymptomsSkin and Connective Tissue Diseases

Criteria

6 inclusion criteria required to participate
Female and male patients aged ≥ 18 years.
Patients clinically diagnosed with keloids.
Patients with at least two keloid lesions located on different sides but in similar anatomical regions.
Keloid lesion size is limited to ≤ 5 cm².
Show More Criteria
7 exclusion criteria prevent from participating
History of hypersensitivity to botulinum toxin.
Pregnant and breastfeeding women.
Patients currently using hormonal contraceptives.
Patients undergoing long-term systemic corticosteroid therapy.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Twenty keloid patients will be injected botulinum toxin A intralesional every 4 weeks.

Group II

Active Comparator
Twenty keloid patients will be injected triamcinolone acetonide intralesional every 4 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hasan Sadikin General Hospital

Bandung, IndonesiaOpen Hasan Sadikin General Hospital in Google Maps
SuspendedOne Study Center