Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-02-24 @ 5:50 AM
Study NCT ID:
NCT05710068
Status:
COMPLETED
Last Update Posted:
2023-02-02
First Post:
2023-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of RF Microneedle on Photoaging Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010859', 'term': 'Pigmentation Disorders'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077442', 'term': 'Lidocaine, Prilocaine Drug Combination'}], 'ancestors': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011318', 'term': 'Prilocaine'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'split lesion study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2023-01-24', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of modified melasma area severity index score', 'timeFrame': 'Every 1 month up to 8 months', 'description': 'Change of modified melasma area severity index score'}, {'measure': 'Change of lightness value', 'timeFrame': 'Every 1 month up to 8 months', 'description': 'Change of lightness value by a chromometer'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pigmentation', 'Pigmentation Disorder']}, 'referencesModule': {'references': [{'pmid': '38200171', 'type': 'DERIVED', 'citation': 'Han HJ, Kim JC, Park YJ, Kang HY. Targeting the dermis for melasma maintenance treatment. Sci Rep. 2024 Jan 10;14(1):949. doi: 10.1038/s41598-023-51133-w.'}]}, 'descriptionModule': {'briefSummary': 'Melasma relapse is almost common after discontinuation of conventional treatment. Recent studies have suggested that photoaging dermis is main pathomechanism of melasma emphasizing stromal targeting therapy. Therefore, we investigated maintenance effect of microneedle radiofrequency (RF) for melasma treatment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult more than 19 years old\n* Melasma clinically diagnosed by three dermatologists\n\nExclusion Criteria:\n\n* Aesthetic medical procedures in three months prior to the study\n* Use of topical depigmenting agents in three months prior to the study\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT05710068', 'briefTitle': 'Effects of RF Microneedle on Photoaging Skin', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'RF Microneedle Therapy Maintains the Treatment Effect of Melasma: A 32-week, Prospective, Randomized Split-face Study', 'orgStudyIdInfo': {'id': 'AJOUIRB-INT-2021-133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional therapy with RF microneedle', 'description': 'Half face Oral tranexamic acid combined with triple combination cream with RF microneedle', 'interventionNames': ['Device: RF Microneedle', 'Drug: Combination cream']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional therapy', 'description': 'Half face Oral tranexamic acid combined with triple combination cream', 'interventionNames': ['Drug: Combination cream']}], 'interventions': [{'name': 'RF Microneedle', 'type': 'DEVICE', 'description': 'Pulsed-type RF device in bipolar mode with 25 non-insulated microneedles every 2 weeks for 6 month', 'armGroupLabels': ['Conventional therapy with RF microneedle']}, {'name': 'Combination cream', 'type': 'DRUG', 'description': '5% hydroquinone, 0.003% tretinoin, and 1% hydrocortisone twice daily for 2 months', 'armGroupLabels': ['Conventional therapy', 'Conventional therapy with RF microneedle']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Fellow', 'investigatorFullName': 'Jin Cheol Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}