| CTRI Number |
CTRI/2024/01/061930 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of intralesional novel triple therapy injection Vs steroid injection in the treatment of keloid |
|
Scientific Title of Study
|
Efficacy and side effects of Intralesional Novel Triple
Medicine Combination Injections Vs Intralesional Triamcinolone Acetonide
injections for the treatment of keloid. – A Randomized Control Trial. |
| Trial Acronym |
Efficacy and side effects of Intralesional Novel Triple
Medicine Combination Injections Vs Intralesional Triamcinolone Acetonide
injections for the treatment of keloid. – A Randomized Control Tria |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANJAY KUMAR MENON T |
| Designation |
Postgraduate in MD DVL |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Room no.21, B block, Department of Dermatology,Aarupadai Veedu Medical College Kirumampakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9544100942 |
| Fax |
|
| Email |
sanjaymenon2504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Damayandhi K |
| Designation |
Associate Professor in DVL Department |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Room no.21, B block, Department of Dermatology,Aarupadai Veedu Medical College Kirumampakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9488511884 |
| Fax |
|
| Email |
deepakaliyaperumal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Damayandhi K |
| Designation |
Associate Professor in DVL Department |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Room no.21, B block, Department of Dermatology, Aarupadai Veedu Medical College, Kirumampakkam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9488511884 |
| Fax |
|
| Email |
deepakaliyaperumal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.21, B block, Department of Dermatology, Aarupadai Veedu Medical College, Kirumampakkam Pondicherry |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College, Kirumampakkam, Pondicherry |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sanjay Kumar Menon T |
Aarupadai Veedu Medical College |
Department OF Dermatology Venerology And Leprology Block C Kirumampakkam Pondicherry
Pondicherry
PONDICHERRY |
9544100942
sanjaymenon2504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AVMC INSTITUTIONAL HUMAN ETHICAL COMMITEE |
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 |
Intralesional Novel Triple
Medicine Combination Injections |
Intralesional Novel Triple
Medicine Combination Injections done at every 3 weeks for 4 Sessions
(0,3,6,9 weeks) and follow up at monthly intervals for 3 months. |
| Comparator Agent |
Intralesional Triamcinolone Acetonide injection |
Intralesional Triamcinolone Acetonide injection done at every 3 weeks for 4 Sessions (0,3,6,9 weeks) and follow up at monthly intervals for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with keloids.
2.Age group of 15-65 years.
3.Both gender.
4.Consenting patients for the study. |
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactating women.
2.Heart Disease.
3.Liver And Kidney Disease.
4.Immunocompromised patients.
5.H/O Previous treatment.
6.Non-compliant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The Vancouver Scar Scale Score
Primary outcome to assess treatment response |
At Baseline 3weeks 9weeks 12 weeks & followed up further 3 months at monthly intervals |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Improvement based on Photographic Document |
At Baseline 3weeks 9weeks 12 weeks & followed up further 3 months at monthly intervals |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 benign dermal fibroproliferative nodular lesions that tends to arise from skin trauma or other events.Many treatment modalities have been explored and have been reported to be beneficial. Clinicians are conducting researches for refining the use of common therapies (steroids & radiation). Anti-inflammatory and chemotherapeutic molecules, procedural focused therapies (cryotherapy and lasers), have also found a role in reducing keloid symptomatology. Despite the growing literature investigating reliable methods for keloid management, there are no standardized guidelines or treatment protocols supported by academic governing bodies.Treatment of keloids seldom result in complete resolution of symptoms and recurrence is commonly seen. Hence there is a need for novel treatment modalities.In this study we aim to compare the efficacy of Novel Triple Medicine Combination Injections Vs Triamcinolone Acetonide Injections for the treatment of Keloid as a better treatment modality. |