Cryotherapy + Triamcinolone for Keloid Scars
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether cryotherapy (a quick freezing treatment) before a steroid injection can make treating keloid and hypertrophic scars less painful and easier for doctors to administer. The trial aims to determine if this method reduces pain and injection resistance compared to using the steroid alone. It involves treating one half of a scar with both cryotherapy and a steroid injection (intralesional triamcinolone) and the other half with just the steroid. The trial seeks adults with keloids or hypertrophic scars who already plan to receive steroid injections and have scars suitable for this split-treatment approach. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on treating scars with cryotherapy and steroid injections, so it's best to ask the trial coordinators for guidance.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that applying liquid nitrogen directly on scars is generally safe and well-tolerated. Studies have found it can reduce scar size and alleviate pain and itching without causing major side effects. However, it might change skin color or cause additional scarring in some cases.
Research also supports the safety and effectiveness of triamcinolone injections for treating keloids and thickened scars. Most individuals tolerate this treatment well, though results can vary. Some studies have reported positive outcomes in reducing scar size and symptoms over time.
Overall, past studies have demonstrated the safety of both treatments, but individual experiences may vary.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this keloid scar treatment because it combines cryotherapy with triamcinolone injections, potentially offering a more effective approach. Unlike standard treatments that often rely solely on steroid injections, this method uses cryoanesthesia with liquid nitrogen first, which may enhance the steroid's penetration and effectiveness. This combination could lead to better scar reduction and faster results, making it a promising option for those struggling with keloid scars.
What evidence suggests that cryotherapy with triamcinolone is effective for reducing pain and injection resistance in keloid scars?
Research has shown that cryotherapy can reduce the size of keloid scars and ease symptoms like pain and itching, with few side effects. Similarly, intralesional triamcinolone, a type of steroid injection, has successfully flattened keloid scars. Specifically, after 10 years, 71% of treated scars were completely flattened, and the same percentage of patients experienced symptom relief. In this trial, one half of the keloid will receive both cryotherapy and triamcinolone, while the other half will receive triamcinolone alone. Combining cryotherapy with triamcinolone might enhance these positive results, making treatments more comfortable and possibly more effective.13678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive topical cryotherapy followed by intralesional corticosteroid injections to evaluate pain and injection resistance
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sonal Choudhary
Lead Sponsor
Citations
Intralesional Cryotherapy for the Treatment of Keloid Scars
IL cryotherapy for the treatment of keloid scars shows favorable results in terms of volume reduction and alleviated complaints of pain and pruritus.
Intralesional cryotherapy for hypertrophic scars and keloids
The published evidence would suggest that it achieves reductions in scar volumes, reduces associated symptoms and does so with few adverse effects.
A new argon gas-based device for the treatment of keloid ...
Scar pigmentation recovered in 62% of all keloid scars within 12 months. Five out of 30 (17%) scars recurred within 12 months, three of which had previously ...
Study Details | NCT01994616 | Prospective Evaluation of ...
This prospective evaluation studies the effectiveness of IL cryotherapy in treating keloids and hypertrophic scars in a large population of ...
5.
journals.lww.com
journals.lww.com/idoj/fulltext/2025/05000/a_randomized_study_to_evaluate_the_efficacy_and.7.aspxA Randomized Study to Evaluate the Efficacy and Adverse...
Successful use of liquid nitrogen cryotherapy in keloids was reported by Zouboulis et al. 13 and Ernst et al. 14 It causes direct tissue injury by ...
Topical Cryotherapy and Keloid/Hypertrophic Scars
The provider will then administer the intervention; one half of the keloid will receive cryoanesthesia with liquid nitrogen spray (~10 seconds).
7.
angelmedical.co.uk
angelmedical.co.uk/wp-content/uploads/2023/08/intralesional-cryosurgery-Oboyle-1.pdfIntralesional cryotherapy for hypertrophic scars and keloids
Despite this, consistent findings from case series suggest that the technique is safe and achieves good scar reduction with very few treatments. Adverse effects ...
Extralesional cryotherapy combined with intralesional ...
Existing cryotherapy applicators that use liquid nitrogen often cause undesirable hypopigmentation or scarring, since their freez- ing point ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.