NCT07336368

Topical Cryotherapy and Keloid/Hypertrophic Scars

Topical Cryotherapy to Reduce Pain During Steroid Injections for Keloid and Hypertrophic Scars: A Pilot Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sonal Choudhary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine whether the application of brief topical cryotherapy immediately before intralesional corticosteroid injections can reduce pain and injection resistance during routine treatment of keloid and hypertrophic scars in adult patients. The main questions it aims to answer are: Does topical cryotherapy applied before intralesional triamcinolone injection impact pain perceptions for participants with keloids or hypertrophic scars? Does topical cryotherapy affect provider-assessed injection resistance compared with standard injection alone? Researchers will split the keloid/hypertrophic scar into two halves. One half will be treated with cryotherapy followed by steroid injection, while the other half will be treated with steroid injection alone to evaluate differences in pain perception and injection resistance. Participants will rate pain after each injection using a 10-point numeric pain scale. Clinicians will rate the resistance after each injection using a 10-point numeric scale.

Conditions

• Keloid Scars
• Hypertrophic Scars

Interventions

Type	Name	Description
DEVICE	Cryotherapy with liquid nitrogen	liquid nitrogen spray (\~10 seconds)
DRUG	Intralesional Triamcinolone 10 mg/ml	Intralesional triamcinolone

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2026-01-13
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study