Keloid ScarsPhase 3NCT07336368
Topical Cryotherapy and Keloid/Hypertrophic Scars
A Phase 3 study testing Cryotherapy with liquid nitrogen and Intralesional Triamcinolone 10 mg/ml in people with Keloid Scars and Hypertrophic Scars, run by Sonal Choudhary at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid Scars, Hypertrophic Scars
- What is being tested?
- Cryotherapy with liquid nitrogen and Intralesional Triamcinolone 10 mg/ml
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-3427
Sonal Choudhary, MD, 7867182737, choudharys@upmc.edu
About this study
Official title: Topical Cryotherapy to Reduce Pain During Steroid Injections for Keloid and Hypertrophic Scars: A Pilot Study
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:
Read more
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.
- Conditions
- Keloid Scars, Hypertrophic Scars
- Being tested
- Cryotherapy with liquid nitrogen, Intralesional Triamcinolone 10 mg/ml
- Keywords
- Keloid scars, Hypertrophic scars, Cryotherapy, Intralesional corticosteroids, Pain reduction, Injection resistance, Injection pain
- Medical subject headings
- Keloid, Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy with liquid nitrogenDevice
liquid nitrogen spray (~10 seconds)
Intralesional Triamcinolone 10 mg/mlDrug
Intralesional triamcinolone
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy + Steroids vs Steroids alone | Experimental | 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. Receives: Device: Cryotherapy with liquid nitrogen; Drug: Intralesional Triamcinolone 10 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Immediately following intralesional corticosteroid injection (same visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start10 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonal Choudhary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sonal Choudhary, University of Pittsburgh
- Investigators
- Sonal Choudhary, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336368
- Sponsor's protocol ID
- STUDY25080173
- Status last verified
- May 2026
- First submitted
- 10 Jan 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified individual participant data will not be shared to protect participants' privacy; only aggregate results will be reported.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Cryotherapy to Reduce Pain During Steroid Injections for Keloid and Hypertrophic Scars: A Pilot Study
- ClinicalTrials.gov ID
- NCT07336368
- Acronym / sponsor ID
- STUDY25080173
- Conditions
- Keloid Scars, Hypertrophic Scars
- Keywords
- Keloid scars, Hypertrophic scars, Cryotherapy, Intralesional corticosteroids, Pain reduction, Injection resistance, Injection pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sonal ChoudharyUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy + Steroids vs Steroids alone | Experimental | Device: Cryotherapy with liquid nitrogen, Drug: Intralesional Triamcinolone 10 mg/mlA 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy with liquid nitrogenliquid nitrogen spray (~10 seconds) | Device | Cryotherapy + Steroids vs Steroids alone |
| Intralesional Triamcinolone 10 mg/mlIntralesional triamcinolone | Drug | Cryotherapy + Steroids vs Steroids alone |
Primary outcome
Patient pain perceptions
Time frame: Immediately following intralesional corticosteroid injection (same visit)
Pain perception during intralesional corticosteroid injection will be assessed using a patient-reported numeric rating scale (0 = No pain, 10 = Very severe pain).
Provider-reported resistance of injection
Time frame: Immediately following intralesional corticosteroid injection (same visit)
Dermatology providers will rate resistance of the intralesional corticosteroid injection using a 10-point numeric scale (0 = No resistance to 10 = Very strong resistance).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared to protect participants' privacy; only aggregate results will be reported.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonal Choudhary principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cryotherapy with liquid nitrogen and Intralesional Triamcinolone 10 mg/ml in people with Keloid Scars and Hypertrophic Scars, run by Sonal Choudhary at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonal Choudhary, MD (7867182737, choudharys@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient pain perceptions (time frame: Immediately following intralesional corticosteroid injection (same visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.