Cryotherapy + Triamcinolone for Keloid Scars

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Sonal Choudhary

Must be taking: Corticosteroids

Disqualifiers: Facial scars, Prior treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Adults over 18 with keloids or hypertrophic scars, who can consent and complete pain assessments in English. They should have a scar that's big enough to be split into two areas for different treatments.

Inclusion Criteria

I can give consent and report my pain in English.

I am an adult with keloids or hypertrophic scars and will receive TAC injections as part of my treatment.

I have a scar that is big enough for split-treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive topical cryotherapy followed by intralesional corticosteroid injections to evaluate pain and injection resistance

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cryotherapy with liquid nitrogen
• Intralesional Triamcinolone

Trial Overview

The trial is testing if cooling the skin with cryotherapy before injecting steroids reduces pain and resistance during treatment of scars. Each participant's scar will be divided; one side gets cryo then steroid, the other just steroid.

How Is the Trial Designed?

Group I: Cryotherapy + Steroids vs Steroids alone Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Sonal Choudhary

Lead Sponsor