Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:41 PM
Study NCT ID:
NCT07336368
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Cryotherapy and Keloid/Hypertrophic Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}, {'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], 'ancestors': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017679', 'term': 'Cryotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-01-10', 'studyFirstSubmitQcDate': '2026-01-10', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient pain perceptions', 'timeFrame': 'Immediately following intralesional corticosteroid injection (same visit)', 'description': 'Pain perception during intralesional corticosteroid injection will be assessed using a patient-reported numeric rating scale (0 = No pain, 10 = Very severe pain).'}, {'measure': 'Provider-reported resistance of injection', 'timeFrame': 'Immediately following intralesional corticosteroid injection (same visit)', 'description': 'Dermatology providers will rate resistance of the intralesional corticosteroid injection using a 10-point numeric scale (0 = No resistance to 10 = Very strong resistance).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Keloid scars', 'Hypertrophic scars', 'Cryotherapy', 'Intralesional corticosteroids', 'Pain reduction', 'Injection resistance', 'Injection pain'], 'conditions': ['Keloid Scars', 'Hypertrophic Scars']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\nDoes topical cryotherapy applied before intralesional triamcinolone injection impact pain perceptions for participants with keloids or hypertrophic scars?\n\nDoes topical cryotherapy affect provider-assessed injection resistance compared with standard injection alone?\n\nResearchers 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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years) with keloids or hypertrophic scars already scheduled to receive intralesional triamcinolone (TAC) as part of routine care.\n* At least one keloid or hypertrophic scar with two comparable regions (≥2 cm each) suitable for split-treatment.\n* Able to provide informed consent and complete pain assessments in English.\n\nExclusion Criteria:\n\n* Keloid or hypertrophic scar located on the face (except earlobes), excluded for cosmetic reasons.\n* Prior treatment to the study-selected keloid/hypertrophic scar based on self-report.\n* Inability to complete study assessments due to cognitive or language barriers.'}, 'identificationModule': {'nctId': 'NCT07336368', 'briefTitle': 'Topical Cryotherapy and Keloid/Hypertrophic Scars', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Topical Cryotherapy to Reduce Pain During Steroid Injections for Keloid and Hypertrophic Scars: A Pilot Study', 'orgStudyIdInfo': {'id': 'STUDY25080173'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cryotherapy + Steroids vs Steroids alone', '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.', 'interventionNames': ['Device: Cryotherapy with liquid nitrogen', 'Drug: Intralesional Triamcinolone 10 mg/ml']}], 'interventions': [{'name': 'Cryotherapy with liquid nitrogen', 'type': 'DEVICE', 'description': 'liquid nitrogen spray (\\~10 seconds)', 'armGroupLabels': ['Cryotherapy + Steroids vs Steroids alone']}, {'name': 'Intralesional Triamcinolone 10 mg/ml', 'type': 'DRUG', 'description': 'Intralesional triamcinolone', 'armGroupLabels': ['Cryotherapy + Steroids vs Steroids alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213-3427', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sonal Choudhary, MD', 'role': 'CONTACT', 'email': 'choudharys@upmc.edu', 'phone': '7867182737'}], 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Sonal Choudhary, MD', 'role': 'CONTACT', 'email': 'choudharys@upmc.edu', 'phone': '7867182737'}], 'overallOfficials': [{'name': 'Sonal Choudhary', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "De-identified individual participant data will not be shared to protect participants' privacy; only aggregate results will be reported."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sonal Choudhary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sonal Choudhary', 'investigatorAffiliation': 'University of Pittsburgh'}}}}