Topical Cryotherapy and Keloid/Hypertrophic Scars

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSonal Choudhary

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Cryotherapy with liquid nitrogen
  • Intralesional Triamcinolone 10 mg/ml

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sonal Choudhary

Lead sponsor

University of Pittsburgh

Sponsor institution