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.

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 InterventionsEach 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.