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Topical Cryotherapy and Keloid/Hypertrophic Scars

NCT07336368 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-06

No results posted yet for this study

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

Interventions

DEVICE

Cryotherapy with liquid nitrogen

liquid nitrogen spray (\~10 seconds)

DRUG

Intralesional Triamcinolone 10 mg/ml

Intralesional triamcinolone

Sponsors & Collaborators

  • Sonal Choudhary

    lead OTHER

Principal Investigators

  • Sonal Choudhary · University of Pittsburgh

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-06-30
Completion
2027-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07336368 on ClinicalTrials.gov