Topical Cryotherapy and Keloid/Hypertrophic Scars

NCT ID: NCT07336368

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2026-08-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cryotherapy with liquid nitrogen

Intervention Type: DEVICE

liquid nitrogen spray (\~10 seconds)

Intralesional Triamcinolone 10 mg/ml

Intervention Type: DRUG

Intralesional triamcinolone

Interventions

Cryotherapy with liquid nitrogen

liquid nitrogen spray (\~10 seconds)

Intervention Type: DEVICE

Intralesional Triamcinolone 10 mg/ml

Intralesional triamcinolone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sonal Choudhary

OTHER

Sponsor Role: lead

Responsible Party

Sonal Choudhary

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sonal Choudhary

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sonal Choudhary, MD

Role: CONTACT

choudharys@upmc.edu

7867182737

Facility Contacts

Sonal Choudhary, MD

Role: primary

choudharys@upmc.edu

7867182737

Other Identifiers

STUDY25080173

Identifier Type: -

Identifier Source: org_study_id