| CTRI Number |
CTRI/2026/02/102742 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Intralesional Triamcinolone versus Alternating Triamcinolone and Insulin in the Keloid patients |
|
Scientific Title of Study
|
A Hospital Based Randomized Controlled Trial Comparing the Efficacy of Intralesional Triamcinolone versus Alternating Intralesional Triamcinolone and Insulin in the Management of Keloids |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Daiya |
| Designation |
Post graduate student |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
ROOM NO: 226, Dept of dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh. Gorakhpur UTTAR PRADESH 273008 India
Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
6377297151 |
| Fax |
|
| Email |
ravidaiya2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Kumar Gupta |
| Designation |
Professor and Head, dept. of dermatology, AIIMS Gorakhpur |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
ROOM NO: 226, Dept of dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh. Gorakhpur UTTAR PRADESH 273008 India
Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9838844937 |
| Fax |
|
| Email |
dr.sunil_30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Daiya |
| Designation |
Post graduate student |
| Affiliation |
All India Institute of Medical Sciences, Gorakhpur |
| Address |
ROOM NO: 226, Dept of dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh. Gorakhpur UTTAR PRADESH 273008 India
Gorakhpur
UTTAR PRADESH
273008
India
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
6377297151 |
| Fax |
|
| Email |
ravidaiya2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Gorakhpur, Kunraghat,Gorakhpur,Uttarpradesh, India Pincode-273008 |
|
|
Primary Sponsor
|
| Name |
Dr Ravi Daiya |
| Address |
Room no.238,PG boys hostel, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh, India. PIN code: 273008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ravi Daiya |
All India Institute of Medical Sciences Gorakhpur |
Room no 226, OPD block, dept. of dermatology and venereology, AIIMS Gorakhpur Gorakhpur UTTAR PRADESH
Gorakhpur
UTTAR PRADESH
Gorakhpur
UTTAR PRADESH |
6377297151
ravidaiya2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, AIIMS Gorakhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L918||Other hypertrophic disorders of the skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 receive Triamcinolone at Weeks 0,6 and 12 and Insulin at Weeks 3,9 and 15, following a crossover/alternating pattern. The total duration of intervention will be for total of 18 weeks and further 12 weeks follow up will be done, making total duration of study 30 weeks.
Dose is 10 IU/cm3,intralesional with concentration of short acting insulin(40IU/ml) |
| Comparator Agent |
Triamcinolone Acetonide |
Intralesional Triamcinolone Acetonide every 3 weeks sessions for 18 weeks. The total duration of intervention will be for total of 18 weeks and further 12 weeks follow up will be done ,making total duration of study 30 weeks.
Dose is 0.1 ml/cm3, intralesional with concentration of (40mg/ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 stiffness |
at 0, 18 weeks, 30 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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). |
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. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Keloids are benign fibroproliferative growths that arise due to an exaggerated wound healing response following cutaneous injury. They represent a significant therapeutic challenge owing to their high recurrence rates and variable response to conventional modalities. Intralesional corticosteroids, particularly Triamcinolone acetonide (TAC), are widely regarded as the first-line treatment; however, they are often limited by suboptimal efficacy and local adverse effects. Insulin has been reported to possess tissue remodeling, angiogenic, and anti-fibrotic properties that may enhance scar maturity and improve clinical outcomes. This randomized controlled trial aims to compare the efficacy of intralesional Triamcinolone alone versus alternating intralesional Triamcinolone and Insulin in the management of keloids. Patients will receive monthly sessions of either intralesional Triamcinolone or alternating intralesional Triamcinolone and Insulin for 18 weeks, followed by a 12 weeks observation period. The therapeutic response will be evaluated using the Patient and observer scar assessment scale(POSAS) at baseline, 18 weeks, and 30 weeks. |