Keloids Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Contact Information
Primary
Sonal Choudhary, MD
choudharys@upmc.edu
7867182737
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2026-08
Participants
Target number of participants: 30
Treatments
Experimental: Cryotherapy + Steroids vs Steroids alone
A provider will divide the identified keloid into two halves. The division will be marked down the center using a sterile skin marker under standard aseptic conditions. The provider will then administer the intervention; one half of the keloid will receive cryoanesthesia with liquid nitrogen spray (\~10 seconds). Within the next 60 seconds, standard intralesional triamcinolone (10-40 mg/mL) will be injected in that half using an identical needle gauge, depth, and volume planned for clinical care. The other half will receive standard intralesional triamcinolone only with an identical injection technique and dose.
Related Therapeutic Areas
Sponsors
Leads: Sonal Choudhary

This content was sourced from clinicaltrials.gov