Topical Cryotherapy and Keloid/Hypertrophic Scars

Phase 3RecruitingNCT07336368

Sonal Choudhary30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Keloid Scars Hypertrophic Scars

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Patient pain perceptions

Pain perception during intralesional corticosteroid injection will be assessed using a patient-reported numeric rating scale (0 = No pain, 10 = Very severe pain).

Time frame: Immediately following intralesional corticosteroid injection (same visit)

Provider-reported resistance of injection

Dermatology providers will rate resistance of the intralesional corticosteroid injection using a 10-point numeric scale (0 = No resistance to 10 = Very strong resistance).