Topical Cryotherapy and Keloid/Hypertrophic Scars
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cryotherapy with liquid nitrogen, Intralesional Triamcinolone 10 mg/ml.
- Who it may be relevant to
- Registry conditions: Keloid Scars, Hypertrophic Scars. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Topical Cryotherapy to Reduce Pain During Steroid Injections for Keloid and Hypertrophic Scars: A Pilot Study
Overview
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.
Interventions
- Device Cryotherapy with liquid nitrogen
liquid nitrogen spray (\~10 seconds) - Drug Intralesional Triamcinolone 10 mg/ml
Intralesional triamcinolone
Primary outcome measures
- Patient pain perceptions [Time frame: Immediately following intralesional corticosteroid injection (same visit)]
- Provider-reported resistance of injection [Time frame: Immediately following intralesional corticosteroid injection (same visit)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT07336368 · STUDY25080173