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Effect of Intralesional Triamcinolone versus Alternating Triamcinolone and Insulin in the Keloid patients

A Hospital Based Randomized Controlled Trial Comparing the Efficacy of Intralesional Triamcinolone versus Alternating Intralesional Triamcinolone and Insulin in the Management of Keloids - Nil

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102742
Enrollment
120
Registered
2026-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L918- Other hypertrophic disorders of the skin

Interventions

Intervention1: Triamcinolone acetonide and short acting insulin: Alternating Therapy Intralesional Triamcinolone followed by Insulin on alternate sessions (Weeks 0, 3, 6, 9, 12,15).Patients will rec

Sponsors

Dr Ravi Daiya
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactRavi Daiya

All India Institute of Medical Sciences, Gorakhpur

dr.sunil_30@yahoo.co.in9838844937

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026