FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092797 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on people with keloids comparing two treatments: Fractional CO2 Laser with triamcinolone versus Microneedling Radio-frequency (MNRF) with triamcinolone to see which is more effective. 
Scientific Title of Study   An open label randomized controlled trial comparing the efficacy of Fractional CO2 laser with topical triamcinolone versus Microneedling Radio-frequency (MNRF) with topical triamcinolone 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  DR FATHIMA HANNA 
Designation  JUNIOR RESIDENT 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Junior Resident Department of Dermatology and Venereology AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  8590987499  
Fax    
Email  drfathimahanna999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR G SETHURAMAN 
Designation  PROFESSOR 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Professor Department of Dermatology and Venereology AIIMS, New Delhi


DELHI
110029
India 
Phone  9871744538  
Fax    
Email  aiimsgsr@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR FATHIMA HANNA 
Designation  JUNIOR RESIDENT 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Junior Resident Department of Dermatology and Venereology AIIMS, New Delhi


DELHI
110029
India 
Phone  8590987499  
Fax    
Email  drfathimahanna999@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Research Section AIIMS, Bharat Bhushan Garg, Room No.5, JLN Auditorium First floor NH 48, Ansari Nagar East, New Delhi, Delhi, India Pin :110029  
 
Primary Sponsor  
Name  DR FATHIMA HANNA 
Address  Junior Resident Department of Dermatology and Venereology AIIMS, New Delhi, India Pin: 110029 
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 
Dr Fathima Hanna  AIIMS, New Delhi  Outpatient facility of Department of Dermatology and Venereology, All India Institute of Medical Sciences, New Delhi.
New Delhi
DELHI 		 8590987499

drfathimahanna999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- AIIMS New Delhi  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 
Comparator Agent  CO2 Laser followed by topical triamcinolone acetonide application  Each patient will receive four fractional CO2 laser treatment sessions, with an interval of 4- 6 weeks between each session. The fractional CO2 laser parameters are as follows: Mode: Synergistic Coagulation and Ablation for Advanced Resurfacing (SCAAR) FXTM; Energy 80-100 mJ; Density 3-5%; Scan size:1x1cm2; Frequency: 150-250 Hz; Number of pulses: 1; Number of pass: 1. Post procedure, a bolus of Tricort - 20-40 mg/ml (face: 20 mg/ml, other areas: 40 mg/ml) is applied to the areas. The treated area is then covered using a transparent film (Tegaderm) or a paraffin gauge dressing. The patients are then instructed to remove the dressing after 24 hours followed by daily application of Tricort - 20- 40 mg/ml with occlusive Tegaderm or Paraffin gauge dressing for 1 week. 
Intervention  Microneedling Radiofrequency (MNRF) followed by topical triamcinolone acetonide application  Each patient will receive four Microneedling Radiofrequency (secret RF 2.0 ) treatment sessions, with an interval of 4-6 weeks between each session. The energy delivery system consists of a disposable tip delivering a 1 cm2 matrix of 25 non-insulated microneedles with a maximum energy output of 20W.Duration: 300 ms; Number of passes:2-4; Insertion depth: 2.5 mm to 3.5 mm, adjusted based on the keloid’s depth. At each specified depth, an additional pass will be performed after rotating the cartridge at 45 degrees to ensure comprehensive coverage. Post procedure, a bolus of Tricort - 20-40 mg/ml (face: 20 mg/ml, other areas: 40 mg/ml) is applied to the areas. The treated area is then covered using a transparent film (Tegaderm) or a paraffin gauge dressing. The patients are then instructed to remove the dressing after 24 hours followed by daily application of Tricort - 20- 40 mg/ml with occlusive Tegaderm or Paraffin gauge dressing for 1 week.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Clinical diagnosis of keloid with a minimum duration of six months.
2. Age 18 - 50 years.
3. Patients with at least two identical lesions, varying in size from 2 x 2 cm2 to 10 x 10 cm2, with size differences not exceeding 50%.
 
 
ExclusionCriteria 
Details  1. Patients who have done any invasive treatment for keloids in the past 12 weeks or any non-invasive treatment in the past 4 weeks.
2. Pregnant and breastfeeding females.
3. Lesions with signs of active infection/ sinuses/ bridging keloid/ earlobe keloids/ lesions suspicious of malignancy.
4. Patients having uncontrolled diabetes/ uncontrolled hypertension/ bleeding disorders/low platelet count/ usage of anticoagulants/ artificial implants or pacemakers.
5. Patients having allergy to local anesthetic.
 
 
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 
1. Reduction in Patient Observer Scar Assessment Scale (POSAS)
2. Reduction in volume of keloid
3. Reduction in thickness of keloid
4. Photographic assessment
5. Side effects of treatment
 		 0, 4, 8, 12, 18, 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Not measuring any secondary objectives.
(Only primary outcomes present) 		 - 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   25/08/2025 
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, titled "An Open Label Randomized Controlled Trial Comparing the Efficacy of Fractional CO2 Laser with Topical Triamcinolone Versus Microneedling Radio-frequency (MNRF) with Topical Triamcinolone in the Treatment of Keloids," aims to evaluate the effectiveness and safety of two advanced treatment modalities for keloids.

Key Highlights:

Background and purpose of study: Keloids are challenging to treat, and no ideal treatment modality exists.Emerging therapies, including lasers and energy-based devices, offer promising options for keloid management.
This study aims to compare the effectiveness of Fractional CO2 Laser and Microneedling Radiofrequency (MNRF).
The Fractional CO2 Laser is widely used for keloid treatment due to its ability to achieve good patient compliance, minimal pain, and favourable aesthetic outcomes.However, it is costly and often associated with prolonged recovery periods and potential complications such as erythema and post-inflammatory hyperpigmentation.
Microneedling Radiofrequency (MNRF), on the other hand, is a more affordable option with shorter downtime, requiring less specialized training and featuring a superior safety profile. If MNRF demonstrates comparable efficacy to the Fractional CO2 Laser, it could serve as a viable alternative for treating keloids.

Objective: To compare the efficacy and safety of fractional CO2 laser with topical triamcinolone versus Microneedling Radio-frequency (MNRF) with topical triamcinolone in the treatment of keloids.

Methodology:

Study Design

  • Type: Open-label randomized controlled trial.
  • Participants: 30 patients with at least two comparable keloid lesions (similar size and characteristics).
  • Setting: Outpatient facility at the Department of Dermatology and Venereology, AIIMS, New Delhi.
  • Duration: 2 years, including treatment sessions and follow-up.

Inclusion Criteria

1.     Clinical diagnosis of keloid with a minimum duration of six months.

2.     Age 18 - 50 years.

3.     Patients with at least two identical lesions, varying in size from 2 x 2 cm2 to 10 x 10 cm2, with sizedifferences not exceeding 50%.

 Exclusion Criteria

1.     Patients who have done any invasive treatment for keloids in the past 12 weeks or any non-invasive treatment inthe past 4 weeks.

2.     Pregnant and breastfeeding females.

3.     Lesions with signs of active infection/ sinuses/ bridging keloid/ earlobe keloids/ lesions suspicious ofmalignancy.

4.     Patients having uncontrolled diabetes/ uncontrolled hypertension/ bleeding disorders/low platelet count/ usage ofanticoagulants/ artificial implants or pacemakers.

5.     Patients having allergy to local anesthetic.

Treatment Interventions

Each patient’s two keloids will be randomized to receive one of the following interventions:

Intervention A: Fractional CO2 Laser with Topical Triamcinolone

  • Procedure:
    • Four treatment sessions at 4-6 week intervals.
    • Laser parameters:
      • Energy: 80-100 mJ.
      • Density: 3-5%.
      • Scan size: 1x1 cm².
      • Number of passes: 1.
    • Post-laser, topical triamcinolone acetonide (20-40 mg/ml) is applied.
    • Area covered with Tegaderm or paraffin dressing for 24 hours.

Intervention B: Microneedling Radio-frequency (MNRF) with Topical Triamcinolone

  • Procedure:
    • Four treatment sessions at 4-6 week intervals.
    • MNRF parameters:
      • Non-insulated microneedles delivering energy at 2.5-3.5 mm depth.
      • Energy: 20W for 300 ms.
      • Multiple passes (2-4), including an additional pass after a 45° rotation at each depth.
    • Post-MNRF, topical triamcinolone acetonide (20-40 mg/ml) is applied.
    • Area covered with Tegaderm or paraffin dressing for 24 hours.
Measures of outcome:

    • Reduction in Patient and Observer Scar Assessment Scale (POSAS).
    • Reduction in Volume of keloid.
    • Reduction in thickness of keloid.
    • Photographic assessment
    • Side effects such as pain, redness, and pigmentation will also be compared.
      Statistical analysis:

    Statistical analysis will be carried out using Stata (StataCorp- LLP). Data will be summarized as number (percentage) and mean ± SD / median (minimum-maximum) for categorical and continuous variables respectively. Baseline categorical and continuous variables will be summarized between the groups. Intention to treat and per protocol analysis will be carried out for outcomes – POSAS (Patient Observer Scar Assessment Scale) score, volume and thickness of keloid. The mean percentage improvement in keloid appearance, as determined through photographic improvement scores evaluated by two blinded observers, will also be analyzed.

    The difference in the means of POSAS (Patient Observer Scar Assessment Scale) score, volume, thickness of keloid and photographic improvement scores will be compared between the two intervention groups using unpaired t-test. The difference in the rates of side effects between the two intervention groups will be compared using Fisher’s exacttest. The two-sided p-value of

    < 0.05 will be considered statistically significant.

     
    Close