Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT07202156
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008548', 'term': 'Melanosis'}], 'ancestors': [{'id': 'D017495', 'term': 'Hyperpigmentation'}, {'id': 'D010859', 'term': 'Pigmentation Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Two-Photon Microscopic Imaging', 'timeFrame': 'The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention', 'description': 'This was to monitor experimental safety and the impact on the skin barrier.'}, {'measure': 'Dermatoscopy', 'timeFrame': 'The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention'}], 'primaryOutcomes': [{'measure': 'percentage reduction in hemi-MASI', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention', 'description': 'mean percentage reduction in hemi-MASI from baseline to week 20'}], 'secondaryOutcomes': [{'measure': 'Patient self-assessment', 'timeFrame': 'week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention', 'description': 'The outcomes were categorized as follows: cured (improvement ≥75%), markedly effective (improvement 50%-75%), effective (improvement 25%-50%), and ineffective (improvement ≤25%). The satisfaction rate was calculated as: Satisfaction rate = (number of cured + markedly effective + effective cases) / total number of cases × 100%'}, {'measure': 'Clinical Efficacy', 'timeFrame': 'week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention', 'description': 'investigators evaluated the melasma or hyperpigmentation on split-face using the following criteria: Cured: \\>90% reduction in pigmented area with virtually disappearance of color upon visual inspection.\n\nMarkedly Effective: \\>60% reduction in area with significant lightening of color.\n\nEffective: \\>30% reduction in area with noticeable lightening of color. Ineffective: \\<30% reduction in area with no significant change in color. The effective rate was calculated as: Effective rate = (number of cured + markedly effective + effective cases) / total number of cases × 100%.'}, {'measure': 'VISIA Digital Skin Analysis', 'timeFrame': 'From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention'}, {'measure': 'Melasma Quality of Life Scale (MELASQOL) Score', 'timeFrame': 'The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melasma (Facial Melasma)']}, 'descriptionModule': {'briefSummary': 'Melasma is a localized, acquired hyperpigmentary skin disorder characterized by well-defined, light to dark brown patches. Based on clinical practice and extensive literature reports, tranexamic acid and reduced Glutathione (GSH) are both applied in the treatment of melasma, but their water-soluble nature presents challenges for transdermal absorption. Our preliminary basic and clinical research has demonstrated that ultrasound-assisted delivery significantly enhances the absorption of tranexamic acid and other water-soluble components. Its effect on the skin barrier is temporary and reversible.\n\nThis study aims to evaluate the efficacy and safety of a compound solution (10% tranexamic acid, 2% GSH) delivered via ultrasound for melasma treatment through a split-face controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-(1) Male or female participants aged 20 to 55 years (inclusive); (2) Subjects clinically diagnosed with melasma and confirmed by the investigator to meet the trial requirements; (3) Subjects willing to comply with follow-up observations and able to provide portrait rights for documentation purposes; (4) Understanding and willingness to participate in the clinical trial, and voluntarily signing a written informed consent form.\n\nExclusion Criteria:\n\n* (1) Females who are pregnant, lactating, or planning to become pregnant during the trial period; (2) Subjects with known allergen to tranexamic acid or any excipient in the investigational product; (3) History of thrombosis or other thrombotic tendencies (e.g., hypertension, hyperlipidemia), or inability to discontinue oral contraceptives, estrogen, or prothrombin complex concentrates during the trial; (4) History of visual or ocular abnormalities (e.g. impaired vision, visual field defects, or fundus hemorrhage/edema) caused by abnormal retinal intravascular coagulation; (5) Patients with skin inflammation who have used topical steroid preparations for more than one month; (6) Presence of skin abnormalities at the trial site, such as nevi, ulcers, or erosions; (7) Any acute or chronic medical history (past or present) that may interfere with the validity or safety assessment of the trial; (8) Clinically significant abnormal laboratory test results prior to the trial; (9) Participation in any other clinical trial within 30 days prior to screening; (10) Any other condition deemed by the investigator to be unsuitable for participation in the study.'}, 'identificationModule': {'nctId': 'NCT07202156', 'briefTitle': 'Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'Clinical Trial on the Efficacy and Safety of Ultrasound-Enhanced Delivery of Compound Tranexamic Acid Solution in the Treatment of Melasma', 'orgStudyIdInfo': {'id': 'SR-820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical treatment with Ultrasound', 'description': '10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² for 10mins', 'interventionNames': ['Device: 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min']}, {'type': 'OTHER', 'label': 'Topical treatment without Ultrasound', 'description': '10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² for 10mins', 'interventionNames': ['Other: 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min']}], 'interventions': [{'name': '10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min', 'type': 'DEVICE', 'description': '5w/cm² Ultrasound-assisted topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins', 'armGroupLabels': ['Topical treatment with Ultrasound']}, {'name': '10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min', 'type': 'OTHER', 'description': 'topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins', 'armGroupLabels': ['Topical treatment without Ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pan Yueyun', 'role': 'CONTACT', 'email': '15851837753@126.com', 'phone': '15851837753'}], 'facility': 'The first Affiliated hospital with Nanjing medical university', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Lu Yan, phD', 'role': 'CONTACT', 'email': 'luyan6289@163.com', 'phone': '13913967126'}, {'name': 'Lu Yan, phD', 'role': 'CONTACT', 'phoneExt': 'Overall Study'}], 'overallOfficials': [{'name': 'Lu Yan', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}