Keloids
Conditions
Brief 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. 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.
Interventions
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.
Sponsors
Maharajgunj Medical Campus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 16 years or more, with keloids or hypertrophic scar more than 10 mm in size
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Height | 12 months | Change in scar height measured in millimeters (mm) using a standardized caliper. |
| Vancouver Scar Scale (VSS) Score | 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 | 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 | 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 | 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) |
Countries
Nepal
Outcome results
None listed