Topical Cryotherapy and Keloid/Hypertrophic Scars

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Sonal Choudhary
Study ID
NCT07336368
Phase
PHASE3
Status
Recruiting

Conditions

  • Hypertrophic Scars
  • Keloid Scars

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryotherapy with liquid nitrogen — DEVICE
    liquid nitrogen spray (\~10 seconds)
  • Intralesional Triamcinolone 10 mg/ml — DRUG
    Intralesional triamcinolone

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Patient pain perceptions [ Time Frame: Immediately following intralesional corticosteroid injection (same visit) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213-3427
Sonal Choudhary, MD
7867182737

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