Topical Cryotherapy and Keloid/Hypertrophic Scars

NCT07336368 | Recruiting Phase 3 FDA Drug FDA Device

• 1 other identifier: STUDY25080173
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Keloid scars; Hypertrophic scars; Cryotherapy; Intralesional corticosteroids; Pain reduction; Injection resistance; Injection pain

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Cryotherapy + Steroids vs Steroids alone

EXPERIMENTAL

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; Drug: Intralesional Triamcinolone 10 mg/ml

Interventions

Cryotherapy with liquid nitrogen DEVICE

liquid nitrogen spray (\~10 seconds)

Cryotherapy + Steroids vs Steroids alone

Intralesional Triamcinolone 10 mg/ml DRUG

Intralesional triamcinolone

Cryotherapy + Steroids vs Steroids alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sonal Choudhary: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213-3427, United States

RECRUITING

MeSH Terms

Conditions

Keloid; Cicatrix, Hypertrophic

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Sonal Choudhary

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonal Choudhary, MD

CONTACT

7867182737; choudharys@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)