KeloidsNCT07034482
Efficacy and Safety of Intralesional 5-Fluorouracil and Triamcinolone Acetonide in Keloids and Hypertrophic Scars
An observational study of Keloids, run by Maharajgunj Medical Campus at 1 site in Nepal.
Trial summary
Pathological scars like keloids and hypertrophic scars (HTS's) cause significant aesthetic, symptomatic and psychological issues to patients. Treatment is challenging with no universally accepted "gold standard" method. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Keloids
- What is being tested?
- Intralesional Triamcinolone 5 mg/ml and Intralesional 5-fluorouracil
- Type of treatment
- Injection or infusion
- How many people
- 41 participants
- Where
- 1 siteNepal
- Study dates
- 1 Sep 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study was conducted in the Department of Plastic Surgery and Burns, Tribhuvan University Teaching Hospital, Kathmandu, Nepal, from September 2020 to September 2021. Eligible participants included patients presenting with keloids or hypertrophic scars who met the predefined inclusion and exclusion criteria.
Who may be able to join
- Patients aged 16 years or more, with keloids or hypertrophic scar more than 10 mm in size
Who cannot join
- Signs of systemic or local infection
- who underwent treatment for same scar in the past 6 months
- Renal failure or liver dysfunction or bone marrow suppression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Combination Therapy of Intralesional 5-Fluorouracil and Triamcinolone Acetonide in Treatment of Keloids and Hypertrophic Scars: A Prospective Study
Pathological scars like keloids and hypertrophic scars (HTS's) cause significant aesthetic, symptomatic and psychological issues to patients. Treatment is challenging with no universally accepted "gold standard" method. Plethora of options is in practice: intralesional (IL) injections, silicon sheets, lasers, cryotherapy, radiotherapy and surgery. This study analysed the effect of combination therapy of IL 5-fluorouracil (5-FU) and triamcinolone acetonide (TAC) in keloids and HTS's.
- Conditions
- Keloids
- Being tested
- Intralesional Triamcinolone 5 mg/ml, Intralesional 5-fluorouracil
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional Triamcinolone 5 mg/mlDrug
Solution containing 5 mg TAC was injected intralesionally, every week for 6 weeks or until the scar flattened, whichever occurred earlier. Not more than 2 ml of the solution was injected per session, using 27G needle pre-mounted on an insulin syringe.
Intralesional 5-fluorouracilDrug
Solution containing 45 mg 5-FU was injected intralesionally, every week for 6 weeks or until the scar flattened, whichever occurred earlier. Not more than 2 ml of the solution was injected per session, using 27G needle pre-mounted on an insulin syringe.
| Study group | Role | What they receive |
|---|---|---|
| Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size | Not described Receives: Drug: Intralesional Triamcinolone 5 mg/ml; Drug: Intralesional 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scar Height
Change in scar height measured in millimeters (mm) using a standardized caliper.
Measured: 12 months
Vancouver Scar Scale (VSS) Score
Change in scar severity based on the Vancouver Scar Scale, a validated tool assessing vascularity, pigmentation, pliability, and height. Scale Range: 0 (normal skin) to 13 (worst scarring)
Measured: 12 months
Patient-Reported Pain Score
Self-reported scar-associated pain using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no pain) to 10 (worst imaginable pain)
Measured: 12 months
Patient-Reported Pruritus Score
Self-reported itch severity related to the scar, measured using a 10-point Visual Analog Scale (VAS).
Scale Range: 0 (no itch) to 10 (worst imaginable itch)
Measured: 12 months
Patient-Reported Scar Appearance Score
Self-reported perception of scar appearance using a 10-point Visual Analog Scale (VAS).
Scale Range: 0 (no visible scar) to 10 (worst possible scar appearance)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharajgunj Medical Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prajjwol Luitel, Maharajgunj Medical Campus
- Investigators
- Prajjwol Luitel, Principal investigator, Institute Of Medicine (IOM), Maharajgunj Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034482
- Sponsor's protocol ID
- 54(6-11)E2.077/078
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combination Therapy of Intralesional 5-Fluorouracil and Triamcinolone Acetonide in Treatment of Keloids and Hypertrophic Scars: A Prospective Study
- ClinicalTrials.gov ID
- NCT07034482
- Acronym / sponsor ID
- 54(6-11)E2.077/078
- Conditions
- Keloids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Maharajgunj Medical CampusUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pathological scars like keloids and hypertrophic scars (HTS's) cause significant aesthetic, symptomatic and psychological issues to patients. Treatment is challenging with no universally accepted "gold standard" method. Plethora of options is in practice: intralesional (IL) injections, silicon sheets, lasers, cryotherapy, radiotherapy and surgery. This study analysed the effect of combination therapy of IL 5-fluorouracil (5-FU) and triamcinolone acetonide (TAC) in keloids and HTS's.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size | – | Drug: Intralesional Triamcinolone 5 mg/ml, Drug: Intralesional 5-fluorouracil |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study was conducted in the Department of Plastic Surgery and Burns, Tribhuvan University Teaching Hospital, Kathmandu, Nepal, from September 2020 to September 2021. Eligible participants included patients presenting with keloids or hypertrophic scars who met the predefined inclusion and exclusion criteria.
Key inclusion criteria (1 listed)
- Patients aged 16 years or more, with keloids or hypertrophic scar more than 10 mm in size
Key exclusion criteria (3 listed)
- Signs of systemic or local infection
- who underwent treatment for same scar in the past 6 months
- Renal failure or liver dysfunction or bone marrow suppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralesional Triamcinolone 5 mg/mlSolution containing 5 mg TAC was injected intralesionally, every week for 6 weeks or until the scar flattened, whichever occurred earlier. Not more than 2 ml of the solution was injected per session, using 27G needle pre-mounted on an insulin syringe. | Drug | Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size |
| Intralesional 5-fluorouracilSolution containing 45 mg 5-FU was injected intralesionally, every week for 6 weeks or until the scar flattened, whichever occurred earlier. Not more than 2 ml of the solution was injected per session, using 27G needle pre-mounted on an insulin syringe. | Drug | Patients aged 16 years or more, with keloids and HTS's more than 10 mm in size |
Primary outcome
Scar Height
Time frame: 12 months
Change in scar height measured in millimeters (mm) using a standardized caliper.
Vancouver Scar Scale (VSS) Score
Time frame: 12 months
Change in scar severity based on the Vancouver Scar Scale, a validated tool assessing vascularity, pigmentation, pliability, and height. Scale Range: 0 (normal skin) to 13 (worst scarring)
Patient-Reported Pain Score
Time frame: 12 months
Self-reported scar-associated pain using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no pain) to 10 (worst imaginable pain)
Patient-Reported Pruritus Score
Time frame: 12 months
Self-reported itch severity related to the scar, measured using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no itch) to 10 (worst imaginable itch)
Patient-Reported Scar Appearance Score
Time frame: 12 months
Self-reported perception of scar appearance using a 10-point Visual Analog Scale (VAS). Scale Range: 0 (no visible scar) to 10 (worst possible scar appearance)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prajjwol Luitel principal investigator
Institute Of Medicine (IOM), Maharajgunj Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keloids, run by Maharajgunj Medical Campus at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scar Height (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.