Topical Cryotherapy and Keloid/Hypertrophic Scars

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertrophic Scars; Keloid Scars
• Intervention / Treatment: Device: Cryotherapy with liquid nitrogen; Drug: Intralesional Triamcinolone 10 mg/ml

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sonal Choudhary, MD; Phone Number: 7867182737; Email: choudharys@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-3427
      • Recruiting
      • University of Pittsburgh
      • Contact: Sonal Choudhary, MD; Phone Number: 7867182737; Email: choudharys@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: Cryotherapy with liquid nitrogen; liquid nitrogen spray (~10 seconds); Drug: Intralesional Triamcinolone 10 mg/ml; Intralesional triamcinolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient pain perceptions	Pain perception during intralesional corticosteroid injection will be assessed using a patient-reported numeric rating scale (0 = No pain, 10 = Very severe pain).	Immediately following intralesional corticosteroid injection (same visit)
Provider-reported resistance of injection	Dermatology providers will rate resistance of the intralesional corticosteroid injection using a 10-point numeric scale (0 = No resistance to 10 = Very strong resistance).	Immediately following intralesional corticosteroid injection (same visit)

Collaborators and Investigators

• Sponsor: Sonal Choudhary
• Investigators: Principal Investigator: Sonal Choudhary, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 10, 2026
• First Submitted That Met QC Criteria: January 10, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cryotherapy; Hypertrophic scars; Injection pain; Pain reduction; Keloid scars; Intralesional corticosteroids; Injection resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Cicatrix; Fibrosis; Collagen Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Cicatrix, Hypertrophic; Keloid; Therapeutics; Cryotherapy
• Other Study ID Numbers: STUDY25080173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data will not be shared to protect participants' privacy; only aggregate results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No