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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.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092797
Enrollment
30
Registered
2025-08-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L918- Other hypertrophic disorders of the skin

Interventions

Intervention1: Microneedling Radiofrequency (MNRF) followed by topical triamcinolone acetonide application: Each patient will receive four Microneedling Radiofrequency (secret RF 2.0 ) treatment sessi
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 comprehensiv
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

Sponsors

DR FATHIMA HANNA
Lead Sponsor

Eligibility

Inclusion criteria

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 size differences not exceeding 50%.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 Timepoint: 0, 4, 8, 12, 18, 24 weeks—

Secondary

MeasureTime frame
Not measuring any secondary objectives. (Only primary outcomes present)Timepoint: -—

Countries

India

Contacts

Public ContactDR FATHIMA HANNA

All India Institute of Medical Sciences, New Delhi

aiimsgsr@gmail.com9871744538

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026