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CTRI Number  CTRI/2026/03/106811 [Registered on: 24/03/2026] Trial Registered Prospectively
Last Modified On: 24/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Therapeutic ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare the effectiveness of combination of drugs to be given in keloid. The participants will either be given The drug combination Triamcinolone acetonide and CO2 laser or Triamcinolone acetonide and Hyaluronidase. The main outcome will be decreased size, symptoms of pain and itching. 
Scientific Title of Study   A Comparative Study Evaluating Efficacy Of Combination Therapy Of Intralesional Triamcinolone Acetonide With Fractional CO2 Laser Versus Intralesional Triamcinolone Acetonide With Hyaluronidase In 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  Pranjal Palan 
Designation  Resident doctor, Department of Skin and VD 
Affiliation  Parul institute of medical sciences and research  
Address  OPD 16, Department of Skin and VD, Parul Sevashram hospital, Waghodia, Vadodara.

Vadodara
GUJARAT
391760
India 
Phone  9998960310  
Fax    
Email  pranjalpalan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Som Lakhani 
Designation  Professor and HOD, Department of Skin and VD 
Affiliation  Parul institute of medical sciences and research  
Address  OPD 16, Department of Skin and VD, Parul Sevashram hospital, Waghodia, Vadodara.

Vadodara
GUJARAT
391760
India 
Phone  9825350198  
Fax    
Email  somlakhani24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pranjal Palan 
Designation  Resident doctor, Department of Skin and VD 
Affiliation  Parul institute of medical sciences and research  
Address  OPD 16, Department of Skin and VD, Parul Sevashram hospital, Waghodia, Vadodara.

Vadodara
GUJARAT
391760
India 
Phone  9998960310  
Fax    
Email  pranjalpalan@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Parul Sevashram Hospital 
Address  OPD - 16, Department of Skin and VD, Parul Sevashram Hospital, Limda, Waghodia, Vadodara. 
Type of Sponsor  Private medical college 
 
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 
Dr Pranjal Palan   Parul sevashram hospital   OPD 16, department of dermatology, Parul sevashram hospital, Parul University campus, Waghodiya, post Limbda
Vadodara
GUJARAT 		 9998960310

pranjalpalan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul University Institutional Ethics Committee for Human Research  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  Triamcinolone acetonide combined with fractional CO2 laser.  Patient treated with fractional CO2 laser followed by intralesional triamcinolone acetonide. Fractional CO2 laser therapy is given with energy 10-30mJ, depending on scar thickness. Triamcinolone is injected immediately after laser therapy. Given at 3 weeks interval for 4 sessions. 
Intervention  Triamcinolone acetonide combined with hyaluronidase.  Patient is treated with hyaluronidase injection along with triamcinolone acetonide: typically 1500 IU of hyaluronidase equivalent to 50 IU per 1 ml of steroid solution is given intralesionally. Given every 3 weeks for 4 sessions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18 to 60 years
Patients with clinically diagnosed keloid
No prior treatment within the last six months
Willingness to participate and provide informed consent
 
 
ExclusionCriteria 
Details  Active infection at the lesion site
2. Known hypersensitivity to corticosteroids
3. Immunocompromised individuals or patients on immuno suppressive therapy
4. Pregnant or lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessing the degree of reduction in keloid size in both treatment groups.
Evaluating the improvement in symptoms like pain and itching.
Determining recurrence rates post treatment
Analysing any adverse effect associated with either treatment approach
 		 First assessment will be done for half an hour after completion of treatment procedure
Next follow up at three months
Last follow up at six months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
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 3/ Phase 4 
Date of First Enrollment (India)   06/04/2026 
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)   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   A comparative study will be carried out at Parul Sevashram hospital which is attached to Parul Institute of Medical Sciences and Research, Parul University, Vadodara on patients presenting with keloids to the outpatient department of Dermatology, venereology and Leprosy and referred from medicine & surgery department. The study will start after taking permission from Institutional Ethics Committee and allotment of CTRI registration number. 

1. All patients meeting the inclusion and exclusion criteria will be subjected to detailed history and meticulous examination as per proforma after taking informed consent.

 

2. Group A (study group): treated with fractional CO2 laser followed by intralesional triamcinolone acetonide. Fractional CO2 laser therapy is given with energy 10-30mJ, depending on scar thickness. Triamcinolone is injected immediately after laser therapy. Sessions every 3 weeks for 4 sessions.

 

Group B (study group): treated with hyaluronidase injection along with triamcinolone acetonide: typically 1500 IU equivalent to 50 IU per 1 ml of steroid solution is given intralesionally. Given every 3 weeks for 4 sessions.

 

3. Patient will be observed for thirty minutes after completion of procedure. Follow up after 3 months to check for degree of reduction and again after 6 months to check for recurrence.

 
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