| CTRI Number |
CTRI/2025/07/090637 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Intralesional Triamcinolone combined with Pentoxifylline versus Intralesional Triamcinolone alone in the treatment of Keloid |
|
Scientific Title of Study
|
A Hospital-Based Randomized Controlled Trial comparing the Efficacy of Intralesional Triamcinolone combined with Pentoxifylline versus Intralesional Triamcinolone alone in the treatment of Keloid
|
| 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, Gorakhpuur |
| 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 |
| 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 |
| 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, Gorakhpuur |
| Address |
ROOM NO: 226, Dept of dermatology, OPD block, AIIMS Gorakhpur, kunraghat, Gorakhpur, Uttar Pradesh.
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 |
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 |
| Comparator Agent |
Intralesional Triamcinolone Acetonide |
Intralesional Triamcinolone Acetonide monthly sessions for 6 months. the total duration of intervention will be monthly for a total of 6 months and further 6 month follow up will be done. |
| Intervention |
Intralesional Triamcinolone acetonide combined with Pentoxifylline |
Intralesional Triamcinolone acetonide combined with Pentoxifylline monthly sessions for 6 months.the total duration of intervention will be monthly for a total of 6 months and further 6 month follow up will be done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18 and 60 years.
2.Presence of clinically diagnosed keloid(s) persisting for at least 6 months.
3.Willing to adhere to the study protocol and complete follow-up assessments.
4.Keloid size between 0.5 cm and 8 cm in diameter.
5.No treatment with intralesional injections within the past 1 month.
|
|
| ExclusionCriteria |
| Details |
1.Active local skin infections or ulceration at the treatment site.
2.History of hypertrophic scar rather than keloid.
3.Known hypersensitivity to triamcinolone or pentoxifylline.
4.Patients with immunosuppressive or systemic corticosteroid therapy.
5.Patients with systemic illness such as uncontrolled diabetes, liver/kidney dysfunction.
6.Pregnant or lactating women.
7.Bleeding diathesis or anticoagulant use.
8.History of epilepsy, peptic ulcer, or recent myocardial infarction (contraindications for pentoxifylline).
9.Participation in another clinical trial within the last 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Vancouver Scar Scale (VSS) score – Assessment of vascularity, pigmentation, pliability, and height. |
At 0, 6 and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Percentage reduction in keloid size (surface area and thickness)
2.Global photographic assessment – Standardized photos evaluation
3.Symptom evaluation – Pain and pruritus assessed at every visit using Visual Analog Scale (VAS).
4.Adverse events – Monitoring of both local and systemic side effects such as skin atrophy, depigmentation, ulceration, and systemic reactions (e.g., GI upset from pentoxifylline).
|
for keloid size and photographic assessment- 0,6,12 months
for symptoms and adverse events - every monthly visit |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
21/07/2025 |
| 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="1"
Months="5"
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
|
Keloids are non-cancerous overgrowths of scar tissue that develops due to an exaggerated healing response following skin injury. They are often challenging to treat and show limited responsiveness to standard therapies. Intralesional corticosteroids(ILS) like Triamcinolone acetonide are frequently used as first line treatment but are associated with high recurrence rates and local side effects. Pentoxifylline(PTX) is known for its anti-inflammatory and antifibrotic effects, may improve therapeutic outcomes when used in combination with ILS. we are comparing the efficacy of ILS combined with PTX vs ILS(standard comparator) alone in treatment of keloid. Patients will undergo monthly sessions of combination treatment(ILS with PTX) or ILS alone for 6 months and further follow up will be done for a 6 months period. We will assess Vancouver scar scale(VSS) score at 0, 6 months and 12 months. |