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Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: Cryotherapy with liquid nitrogen
    liquid nitrogen spray (~10 seconds)
  • Drug: Intralesional Triamcinolone 10 mg/ml
    Intralesional triamcinolone

Recruiting Locations

University of Pittsburgh
Pittsburgh, Pennsylvania 15213-3427
Contact:
Sonal Choudhary, MD
7867182737
choudharys@upmc.edu

More Details

Status
Recruiting
Sponsor
Sonal Choudhary

Study Contact

Sonal Choudhary, MD
7867182737
choudharys@upmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.