Topical Cryotherapy and Keloid/Hypertrophic Scars

Sonal Choudhary

Status and phase: Enrolling; Phase 3

Conditions: Keloid Scars; Hypertrophic Scars

Treatments: Drug: Intralesional Triamcinolone 10 mg/ml; Device: Cryotherapy with liquid nitrogen

Study type: Interventional

Funder types: Other

Identifiers

NCT07336368

STUDY25080173

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cryotherapy + Steroids vs Steroids alone

Experimental group

Description:

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.

Treatment:

Device: Cryotherapy with liquid nitrogen

Drug: Intralesional Triamcinolone 10 mg/ml