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 — DEVICEliquid nitrogen spray (\~10 seconds)
- Intralesional Triamcinolone 10 mg/ml — DRUGIntralesional 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 aloneA 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
- Sonal Choudhary, MD7867182737
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213-3427 |