Health Condition 1: L918- Other hypertrophic disorders of the skin
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 60 years with a clinical diagnosis of keloid(s) more than 6 months in duration. 2. Lesion size between 0.5 cm and 10 cm in diameter. 3. No prior intralesional treatment within the last month. 4. Willing and able to comply with treatment schedule and follow-up visits. 5. Provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Active infection or ulceration at the treatment site. 2. Hypertrophic scar (not keloid). 3. History of allergy to triamcinolone or insulin. 4. Use of systemic steroids or immunosuppressants. 5. Known diabetes mellitus or simultaneous Insulin/ oral hypoglycemic agents use. 6. Significant hepatic, renal, or cardiovascular illness. 7. Pregnant or breastfeeding women. 8. Coagulopathy or current use of anticoagulant medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| POSAS (Patient and Observer Scar Assessment Scale): Both components of POSAS will be completed to evaluate improvements in scar color, thickness, pliability, and surface characteristics, along with patient-reported symptoms such as pain, pruritus, and stiffnessTimepoint: at 0, 18 weeks, 30 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage reduction in keloid size (surface area & thickness) 2.Global photographic assessment Standardized photos evaluation 3.Symptom evaluation Pain & pruritus assessed at every visit using Visual Analog Scale (VAS). 4.Adverse events Monitoring of local side effects (e.g., skin atrophy, pigmentation changes, ulceration, injection site reactions) & systemic effects related to insulin (e.g. hypoglycemia, dizziness, hypersensitivity).Timepoint: for keloid size & photographic assessment- baselin,18 week,30 week for symptoms & adverse events - every 3 weekly visit till 18 weeks ,then lastly at 30 week. | — |
Countries
India
Contacts
All India Institute of Medical Sciences, Gorakhpur