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NCT07336368PHASE3Recruiting

Topical Cryotherapy and Keloid/Hypertrophic Scars

Sonal Choudhary

Start Date

6/10/2026

Completion Date

8/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Adults (≥18 years) with keloids or hypertrophic scars already scheduled to receive intralesional triamcinolone (TAC) as part of routine care. * At least one keloid or hypertrophic scar with two comparable regions (≥2 cm each) suitable for split-treatment. * Able to provide informed consent and complete pain assessments in English. Exclusion Criteria: * Keloid or hypertrophic scar located on the face (except earlobes), excluded for cosmetic reasons. * Prior treatment to the study-selected keloid/hypertrophic scar based on self-report. * Inability to complete study assessments due to cognitive or language barriers.

Interventions

DEVICE

Cryotherapy with liquid nitrogen

DRUG

Intralesional Triamcinolone 10 mg/ml

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Conditions

Keloid ScarsHypertrophic Scars

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania 15213-3427

United States