Recruiting
Phase 3

Cryotherapy with Triamcinolone

Sponsor:

Sonal Choudhary

Code:

NCT07336368

Conditions

Keloid Scars

Hypertrophic Scars

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryotherapy with liquid nitrogen

Intralesional Triamcinolone 10 mg/ml

Study Details

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 ID

NCT07336368

Start date

Jun 10, 2026

Status verified date

May, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Cryotherapy with liquid nitrogen

liquid nitrogen spray (\~10 seconds)

Intralesional Triamcinolone 10 mg/ml

Intralesional triamcinolone

Primary outcome measure

  • Patient pain perceptions [ Time Frame: Immediately following intralesional corticosteroid injection (same visit) ]
  • Provider-reported resistance of injection [ Time Frame: Immediately following intralesional corticosteroid injection (same visit) ]

Central Contacts and Locations

Central contacts

Sonal Choudhary, MD

7867182737choudharys@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213-3427

Contacts

Sonal Choudhary, MD

7867182737choudharys@upmc.edu

More Information

Sponsor

Sonal Choudhary

Last update posted

Jun 12, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sonal Choudhary on 2026-06-12.