Health Condition 1: L918- Other hypertrophic disorders of the skin
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
All India Institute of Medical Science, Jodhpur