| CTRI Number |
CTRI/2025/08/092355 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison study- Is injecting insulin into the keloid as useful as injecting steroid |
|
Scientific Title of Study
|
Efficacy and Safety of Intralesional Insulin in Comparison to Intralesional Corticosteroids in the Management of Keloids: A Non Inferiority Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Nisha |
| Designation |
Postgraduate resident |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Department of Dermatology, Venereology and Leprosy,
Indira Gandhi Medical College and Research Institute, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
7558178284 |
| Fax |
|
| Email |
nishamanogarane04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Saritha Mohanan |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Department of Dermatology, Venereology and Leprosy,
Indira Gandhi Medical College and Research Institute, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9443397873 |
| Fax |
|
| Email |
saritha_mohanan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
M Nisha |
| Designation |
Postgraduate resident |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Department of Dermatology, Venereology and Leprosy,
Indira Gandhi Medical College and Research Institute, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
7558178284 |
| Fax |
|
| Email |
nishamanogarane04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College and Research Institute, Puducherry |
|
|
Primary Sponsor
|
| Name |
Nisha M |
| Address |
Department of Dermatology IGMCRI,
Kathirkamam,
Puducherry- 605009 |
| 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 |
| Dr Nisha M |
Indira Gandhi Medical College and Research Institute |
Outpatient Department no 12
Department of Dermatology
Kathirkamam
Puducherry 605009
Pondicherry
PONDICHERRY |
7558178284
nishamanogarane04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira gandhi medical college and research institute |
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 |
Insulin |
Injecting Inj.Actrapid 10IU per mL into keloid at day 0, Week 3, Week 6, Week 9 |
| Comparator Agent |
Triamcinolone acetonide |
Injecting Inj.Triamcinolone acetonide 40mg per ml into keloid on day 0,Week 3, Week 6, week9 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
No prior treatment for keloids in the past 2 months and are willing to follow up |
|
| ExclusionCriteria |
| Details |
Pregnancy, Lactation, patient on immunosuppressants and anticoagulants, local site infection, ear lobe keloid, hypertrophic scars, diabetes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the effectiveness of keloid severity using Vancouver scar scale |
Baseline, week 9 and week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess and compare individual components of VSS (vascularity, height, pliability and pigmentation) 2.Compare the adverse effect
3.Recurrence rate |
Baseline, week 9 and week 24 |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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 3 |
|
Date of First Enrollment (India)
|
14/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is a single-blinded non inferiority trial that aims to compare the efficacy and safety of intralesional insulin and intralesional corticosteroids in the management of keloids. The study will include patients aged 18 and above with keloids, who will be randomly allocated to receive either intralesional insulin or intralesional triamcinolone acetonide. The primary outcome measure will be the Vancouver Scar Scale (VSS) score, while secondary outcomes will include individual components of VSS, adverse effects, and recurrence rate. The study expects to recruit 94 participants and will be conducted over 24 months. Data collection will be done on presdesigned case record form and stored in Excel. Data analysis will be done as per intention to treat analysis. If proven effective, intralesional insulin could serve as a safe, affordable alternative to steroids in keloid treatment, improving patient outcomes and reducing side effects |