An observational study in Keloids, sponsored by Maharajgunj Medical Campus. Completed at 1 site in Nepal. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Maharajgunj Medical Campus · Observational
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 41 is below the median of 100 across 23 observational studies indexed under Keloid.
Browse Keloid studies →Maharajgunj Medical Campus is the lead sponsor of 8 studies on the registry; none are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Intralesional Triamcinolone 5 mg/ml · Drug: Intralesional 5-fluorouracil
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.
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.
Scar Height
Change in scar height measured in millimeters (mm) using a standardized caliper.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2020 to primary completion in Sep 2021, 12 months.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Maharajgunj Medical Campus