Topical Cryotherapy to Reduce Pain During Steroid Injections for Keloid and Hypertrophic Scars: A Pilot Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Patient pain perceptions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- 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.
Arms & Interventions
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.
Intervention: Cryotherapy with liquid nitrogen (Device)
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.
Intervention: Intralesional Triamcinolone 10 mg/ml (Drug)
Outcomes
Primary Outcomes
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).
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Sonal Choudhary
Assistant Professor
University of Pittsburgh