Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT05488860
Status:
UNKNOWN
Last Update Posted:
2022-08-05
First Post:
2022-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}, {'id': 'D007627', 'term': 'Keloid'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010778', 'term': 'Photochemotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison is designed in each participant. For each individual, two similar hypertrophic scar/keloid or a single hypertrophic scar/keloid is randomly assigned into traditional injection group or piezoelectric divied microneedling group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-term response', 'timeFrame': '1 week after treatment', 'description': 'This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.'}, {'measure': 'Long-term response', 'timeFrame': '1 month after treatment', 'description': 'This is a qualitative item which should be evaluated by comparing the general images and dermoscopic images pre-treatment and post-treatment carefully.'}], 'secondaryOutcomes': [{'measure': 'Pain score during treatment', 'timeFrame': 'Immediately', 'description': 'Using visual analogue scale (score 0-10, 0=no pain, 10=unbearable pain) to evaluate the level of pain'}, {'measure': 'POSAS(The Patient and Observer Scar Assessment Scale) score', 'timeFrame': '1 month after treatment', 'description': 'A widely used scar scale for evaluating the severity of scar by both patients and dermatologists. Score ranged from 11 to 110. The higher score means severer condition of scar.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microneedling', 'Ultrasound', 'Refractory skin diseases', 'Piezoelectric drived'], 'conditions': ['Skin Diseases', 'Hypertrophic Scar', 'Keloid', 'Plantar Wart', 'Warts', 'Skin Tumor']}, 'descriptionModule': {'briefSummary': 'Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases.', 'detailedDescription': 'Piezoelectric drived microneedling treats refractory skin disorders using hollow microneedles assisted by ultrasound. Mechanically, the injection of medicine by hollow microneedling could makes the distribution of medicine more evenly. And the addition of ultrasound technique improves the effectiveness of microneedling. Investigators plan to conduct a pilot study to investigate the efficacy of using piezoelectric drived microneedles in treating refractory skin diseases. Investigators accept participants of hypertrophic scar, keloid and warts. For participants who are not candidates for traditional surgery, investigators will consider to accept carefully.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 16 years\n* Diagnosed by 2 or more professional dermatologists\n* Willing to underwent a new treatment modality\n* Follow up is easy to conduct\n\nExclusion Criteria:\n\n* Poor general condition\n* Bleeding tendency\n* Allergy to drug'}, 'identificationModule': {'nctId': 'NCT05488860', 'briefTitle': 'Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Xiangya Hospital of Central South University'}, 'officialTitle': 'Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study', 'orgStudyIdInfo': {'id': 'XiangyaDerm0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional injection', 'description': 'Intralesional injection of drug by traditional injection needle. This is the traditional approach for drug delivery recommended by international guidelines for each skin diseases.', 'interventionNames': ['Drug: Triamcinolone acetonide(scar)/5-ALA(others)']}, {'type': 'EXPERIMENTAL', 'label': 'Piezoelectric drived microneedling', 'description': 'Intralesional injection of drug by piezoelectric drived microneedles.', 'interventionNames': ['Procedure: Piezoelectric drived microneedling', 'Drug: 5-ALA (a photosensitizer for photodynamic therapy).']}], 'interventions': [{'name': 'Triamcinolone acetonide(scar)/5-ALA(others)', 'type': 'DRUG', 'otherNames': ['Intralesional drug delivery'], 'description': 'For scar, the drug is triamcinolone acetonide.', 'armGroupLabels': ['Traditional injection']}, {'name': 'Piezoelectric drived microneedling', 'type': 'PROCEDURE', 'description': 'Piezoelectric drived microneedling', 'armGroupLabels': ['Piezoelectric drived microneedling']}, {'name': '5-ALA (a photosensitizer for photodynamic therapy).', 'type': 'DRUG', 'description': 'For other diseases, the drug is 5-ALA (a photosensitizer for photodynamic therapy).', 'armGroupLabels': ['Piezoelectric drived microneedling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zixi Jiang', 'role': 'CONTACT', 'email': 'jiangzixi@csu.edu.cn', 'phone': '13278883845'}], 'facility': 'Xiangya Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}