Brief topical cryotherapy before steroid injections for keloid and hypertrophic scars
Topical Cryotherapy to Reduce Pain During Steroid Injections for Keloid and Hypertrophic Scars: A Pilot Study
PHASE3 · University of Pittsburgh · NCT07336368
This study will test whether applying a short burst of topical cryotherapy just before steroid injections lowers pain and makes injections easier for adults getting intralesional triamcinolone for keloid or hypertrophic scars.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07336368 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional trial enrolls adults with keloid or hypertrophic scars who are already scheduled for intralesional triamcinolone. Each eligible scar is split into two comparable regions; one half receives brief liquid nitrogen cryotherapy immediately before the steroid injection and the other half receives the steroid injection alone. Participants rate pain after each injection on a 0–10 numeric scale and clinicians rate injection resistance for each half. The within-scar split design compares patient-reported pain and provider-assessed resistance directly between the two techniques.
Who should consider this trial
Good fit: Adults (age 18 and older) with keloid or hypertrophic scars already planned for intralesional triamcinolone who have at least one scar with two comparable regions of ≥2 cm and can consent and complete assessments in English.
Not a fit: Patients with scars on the face (except earlobes), those who previously treated the selected scar, or those unable to complete assessments due to language or cognitive barriers are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could make steroid injections for keloid and hypertrophic scars less painful and easier to perform.
How similar studies have performed: Local cooling has shown pain-reduction benefits for injections in other settings, but direct split-scar evidence specifically for keloid or hypertrophic scar steroid injections is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Sonal Choudhary — University of Pittsburgh
- Study coordinator: Sonal Choudhary, MD
- Email: choudharys@upmc.edu
- Phone: 7867182737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Keloid Scars, Hypertrophic Scars, Keloid scars, Hypertrophic scars, Cryotherapy, Intralesional corticosteroids, Pain reduction, Injection resistance