FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/058276 [Registered on: 04/10/2023] Trial Registered Prospectively
Last Modified On: 28/09/2023
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 to compare laser and injection therapy vs injection treatment alone in treating keloids.  
Scientific Title of Study   A comparative study on the efficacy of intense pulse Light therapy combined with Intralesional steroids versus Intralesional steroids alone in the treatment 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  DrULAVANYA 
Designation  DERMATOLOGY,VENEREOLOGY AND LEPROLOGY, POST GRADUATE STUDENT 
Affiliation  Government Chengalpattu Medical college and hospital 
Address  Department of DVL, Government Chengalpattu Medical college and hospital, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  9444767687  
Fax    
Email  lavsravi0306@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.R.SINDHUJA 
Designation  M.D.D.V.L-Professor 
Affiliation  Government Chengalpattu Medical college and hospital 
Address  Department of DVL, Government Chengalpattu Medical college and hospital, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  9444767687  
Fax    
Email  dermcliniccmch@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrULAVANYA 
Designation  DERMATOLOGY,VENEREOLOGY AND LEPROLOGY-POST GRADUATE STUDENT 
Affiliation  Government Chengalpattu Medical college and hospital 
Address  Department of DVL, Government Chengalpattu Medical college and hospital, Chengalpattu.

Kancheepuram
TAMIL NADU
603001
India 
Phone  9444767687  
Fax    
Email  lavsravi0306@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology,venereology and leprology, Government chengalpattu medical college, Chengalpattu-603001. 
 
Primary Sponsor  
Name  DrULavanya 
Address  Department of DVL Chengalpattu Medical College Hospital Chengalpattu  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Lavanya  Government chengalpattu medical college  Opd no 44 second floor Department of dvl government chengalpattu medical college chengalpattu
Kancheepuram
TAMIL NADU 		 9444767687

lavsravi0306@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chengalpattu institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  intense pulse light therapy and intralesional steroids  Intense pulse light(530nm and 640nm filter) topically and intralesional steroids (40mg/ml)subcutaneous maximum 6 sittings at 4 weeks interval 
Comparator Agent  intralesional steroids  intralesional steroids(40mg/ml)subcutaneous maximum 6 sittings at 4 weeks interval 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All clinically diagnosed cases of keloid .
Patients who are willing to give informed consent. 
 
ExclusionCriteria 
Details  Before starting the study -
Patients who are pregnant or lactating.
Patients planning for pregnancy.
Patients with history of intake of oral retinoids in the past 6 months.
Patients with signs of active infection or lesions suspicious of malignancy.
Patients with diseases or genetic conditions causing photosensitivity or tending to aggravate after light exposure.
Patients with co-morbidities- DM,SHT,TB,CAD,EPILEPSY,BA.
Patients on Photosensitizing drugs,immunosuppressive drugs,anti coagulants.
Bleeding and coagulation disorders,HIV.

During Study -
If patient develops severe side effects like ulceration / intolerance to pain during the treatment.
If patient wants alternate treatment during the study.
If patient wants to discontinue the treatment. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The end point will be the evaluation of clinical response to both the mode of treatment at 36 weeks after treatment initiation
Responses in between the study will be noticed recorded using Modified Vancouver Scar Scale(MVSS) Physicians Global Assessment (PGA) scale Patients overall satisfaction score 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Safety profile  36 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   09/10/2023 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [lavsravi0306@gmail.com].

  6. For how long will this data be available start date provided 14-08-2023 and end date provided 14-08-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Keloids represent an excessive connective tissue response to injury.Its a benign well demarcated overgrowth of fibrotic tissue which extends beyond the original boundaries of a defect.These are cosmetically distressing,painful or pruritic.
A scar at any site has the potential to become keloidal although the earlobes,chin,neck are vulnerable.Burns,scars or tissue infection lead to hypertrophic scarring.Lesions may follow trivial trauma or inflammatory lesions like acne.Sometimes,keloids can occur spontaneously patlrticularly on upper chest.


 
Close