CTRI/2019/08/020883.

Study name	Study and compare the effect of Intralesional Radiofrequency and carbon dioxide laser in keloid and hypertrophic scar
Methods	Randomised, parallel group, active controlled trial
Participants	Patients with keloid and hypertrophic scar, progressive or stationary lesion, size < 10 cm in any dimension, no previous treatment in last 6 weeks.
Interventions	Intervention1: Intralesional Radiofrequency ablation: the device used‐RF generator. Mode ‐ cut/ coagulation Max. power output of 10 W. Intracath no 22 will be used with the insulation and small nick was made at the base of middle and the tip of a needle. The uninsulated part of the intracath tip will be inserted into the keloid, and the pre‐set energy will be applied to the keloid tissue until a maxi temperature of 90°C will be reached. Injection triamcinolone acetonide 20 mg/mlL will be infiltrated around the margins just after surgery and again after a gap of every 4 weeks for 6 months. The same procedure will be repeated every monthly consequently for 3 months, if needed (until excellent response achieved). Intervention2: carbon dioxide laser surface ablation: technique ‐ single or stage‐wise manner by multiple puncture technique. Small full thickness punctures will be created throughout the keloid tissue with a gap of 1 to 3 mm between the 2 punctures by CO2 laser. Single pulse (for firm keloid) or continuous (for hard keloid) mode will be used with 20 W power. Injection triamcinolone acetonide 20 mg/mL will be infiltrated around the margins just after surgery and again after a gap of every 4 weeks for 6 months. The same procedure will be repeated every monthly consequently for 3 months, if needed (until excellent response achieved).
Outcomes	Primary outcome: improvement in scar severity: excellent response (90 % ‐ almost complete flattening); good response (71 to 90 % ‐ significant flattening); moderate response (51 to 70 % ‐ adequate flattening); poor response (< 50 % ‐ inadequate flattening); time point: 28 weeks Secondary outcomes: size, height, The Vancouver Scar Scale
Starting date	16 September 2019
Contact information	Dr Hita Mehta: Room No.115 First floor Department of Dermatology New OPD building Sir T General hospital Bhavnagar Bhavnagar GUJARAT 364001 India hitamehta88@gmail.com
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