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A study comparing two debulking procedures with steroid treatment for keloid scars

A Randomized Comparative Study of Debulking by Radial Punch Excision versus Intralesional Radiofrequency Ablation accompanied by Intralesional Steroid Injection in the Treatment of Keloids - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110236
Enrollment
64
Registered
2026-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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: Radial Punch Excision (Group A): Group A: Under aseptic conditions and local anesthesia. A 3 mm punch will be done for initial entry, followed by a 2 mm punch for radial excision throug

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-60 years 2. Clinically diagnosed keloids 3. Keloid size: greater than 2 cm to less than 10 cm in greatest dimension and greater than or equal to 0.5 cm in thickness. 4. Keloid duration: greater than or equal to 6 months. 5. Wash-off period a. Topical steroid: 2 weeks b. Intralesional steroids: 4 weeks c. Oral steroid: 4 weeks 6. Willing to provide informed consent and comply with study procedures

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Hypertrophic scars (distinguished from keloids clinically). 3. Active infection at keloid site. 4. Bleeding disorders or anticoagulant therapy. 5. Immunocompromised patients. 6. Concurrent use of immunosuppressive medications.

Design outcomes

Primary

MeasureTime frame
To compare the clinical efficacy of punch excision versus intralesional radiofrequency ablation in keloid debulking using Vancouver Scar Scale (VSS) at 0, 6, 12 weeksTimepoint: At Baseline At 6 weeks At 12 weeks

Secondary

MeasureTime frame
1. To compare percentage volume reduction and Detroit Keloid scale (DKS) scores at 6, and 12 weeks 2. To compare adverse effects in each group (monitored at follow up visit). 3. To comapre the recurrence rate following the procedure. 4. To compare tissue expression analysis of TGF beta and VEGF from central versus active peripheral portions of keloidal tissue. Timepoint: Recurrence rate and adverse events at every follow up visit. Detroit keloid scale and volume reduction at 0, 6, 12 weeks

Countries

India

Contacts

Public ContactDr Suman Patra

All India Institute of Medical Science, Jodhpur

patrohere@gmail.com9650450413

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026