Topical Cryotherapy and Keloid/Hypertrophic Scars
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSonal Choudhary
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Cryotherapy with liquid nitrogen
Deviceliquid nitrogen spray (\~10 seconds)
Intralesional Triamcinolone 10 mg/ml
DrugIntralesional triamcinolone
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Cryotherapy + Steroids vs Steroids aloneExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Patient pain perceptions
Pain perception during intralesional corticosteroid injection will be assessed using a patient-reported numeric rating scale (0 = No pain, 10 = Very severe pain).
Time frame
Immediately following intralesional corticosteroid injection (same visit)2
Provider-reported resistance of injection
Dermatology providers will rate resistance of the intralesional corticosteroid injection using a 10-point numeric scale (0 = No resistance to 10 = Very strong resistance).
Time frame
Immediately following intralesional corticosteroid injection (same visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sonal Choudhary
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov