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NCT Number: NCT07336368

Topical Cryotherapy and Keloid/Hypertrophic Scars

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.

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Key information

Conditions

Keloid Scars Cicatrix Cicatrix, Hypertrophic Collagen Diseases Connective Tissue Diseases Fibrosis Hypertrophic Scars Keloid Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213-3427, United States

Location status: Recruiting

Location contact

Sonal Choudhary, MD

CONTACT

[email protected]

7867182737

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryotherapy with liquid nitrogen

Device

liquid nitrogen spray (~10 seconds)

Intralesional Triamcinolone 10 mg/ml

Drug

Intralesional triamcinolone

Primary outcomes

  1. Patient pain perceptions

    Time frame: Immediately following intralesional corticosteroid injection (same visit)

    Pain perception during intralesional corticosteroid injection will be assessed using a patient-reported numeric rating scale (0 = No pain, 10 = Very severe pain).

  2. Provider-reported resistance of injection

    Time frame: Immediately following intralesional corticosteroid injection (same visit)

    Dermatology providers will rate resistance of the intralesional corticosteroid injection using a 10-point numeric scale (0 = No resistance to 10 = Very strong resistance).

Study contacts

Contact information is provided by the study sponsor or research team.

Sonal Choudhary, MD

CONTACT

[email protected]

7867182737

Sponsors and collaborators

Lead sponsor

Sonal Choudhary

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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