Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-01 @ 11:41 AM
Study NCT ID:
NCT06932393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exosomes for Hairloss Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of localized hair density', 'timeFrame': '3rd month after 3 treatments', 'description': 'Quantify hair counts within designated 1.5 cm × 1.5 cm fixed areas in both the study area and control area, and compare the localized hair density (hair/cm²) between the two areas.'}, {'measure': 'Safety Assessment', 'timeFrame': 'From the initial treatment administration to the subject withdrawal from the study.', 'description': 'Incidence of treatment emergent adverse events (TEAEs)'}, {'measure': 'Comparison of overall hair density', 'timeFrame': '3rd month after 3 treatments', 'description': 'Evaluate and score overall hair density in both the study area and control area using an 8-level assessment scale, followed by a comparative analysis of the two areas.'}], 'secondaryOutcomes': [{'measure': 'Change of hair density', 'timeFrame': '3rd and 6st month after 3 treatments', 'description': 'Change in hair density of study area with the baseline.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hair Loss', 'Exosomes'], 'conditions': ['Hair Loss']}, 'descriptionModule': {'briefSummary': 'Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human mesenchymal stem cells and purified using specific processing. This study is a randomized, double-blind, dose-escalation clinical trial designed to evaluate the efficacy and safety of exosomes therapy for alopecia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects are able to read documents and can sign informed consent.\n2. 18\\~75 years old (including the threshold), gender is not limited.\n3. The subject\'s "hair loss grade" meets the following criteria:\n\n1\\) BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or special type (V1 to V3, or F1 to F3); 2) For female: Ludwig Grade I to II. Or for male: Hamilton-Norwood Grade III to IV; 3) Hair density by phototrichogram: ≤ 190 hair/cm² ; 4. Hair dryness ≥ 5%; 5. Until withdrawal/completion of the study, subjects agree not to undergo any topical treatment for hair loss and agree to use a neutral shampoo.\n\nExclusion Criteria:\n\n1. People with patchy or diffuse baldness, syphilitic alopecia, scarring alopecia, malnutrition, chemotherapy/radiotherapy-induced hair loss.\n2. Those with a combination of diseases that have an impact on hair growth.\n3. Use of medications, medicated shampoos, or hair care products that may interfere with efficacy evaluation within 3 months prior to screening (oral administration of therapeutic agents for androgenetic alopecia must be discontinued for at least 6 months).\n4. Have received scalp radiation and/or laser or surgical therapy within 3 months prior to screening.\n5. Participated or are participating in a interventional clinical trial within 3 months.\n6. Persons with a history of hereditary alopecia areata.\n7. Women who are pregnant or breastfeeding, or male/female subjects whose own/partner\'s pregnancy is planned within 6 months.\n8. Have undergone hair transplantation in the previous 24 months.\n9. Individuals testing positive for active infectious diseases or carriers of communicable pathogens.\n10. Those with keloid, keloid-prone or hyperplastic scarring.\n11. Those who, in the opinion of the investigator, are otherwise unfit to participate in this clinical study.'}, 'identificationModule': {'nctId': 'NCT06932393', 'briefTitle': 'Exosomes for Hairloss Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou Bio-gene Technology Co., Ltd'}, 'officialTitle': 'A Randomized, Double-blind, Single-center, Self-controlled Exploratory Clinical Study of Exosomes for Hairloss Treatment', 'orgStudyIdInfo': {'id': 'BG-CT-24-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exosomes', 'description': 'Subjects will receive 5E8 \\~5E9 particles/cm² of exosome therapy in the study area during the dose escalation phase.', 'interventionNames': ['Biological: exosomes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'The control site will receive the same volume of saline as the exosomes administered in the study site.', 'interventionNames': ['Other: saline']}], 'interventions': [{'name': 'exosomes', 'type': 'BIOLOGICAL', 'otherNames': ['EVs'], 'description': 'Each subject will receive 3 injections with an interval of one month.', 'armGroupLabels': ['exosomes']}, {'name': 'saline', 'type': 'OTHER', 'description': 'Each subject will receive 3 injections with an interval of one month.', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518067', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Jiaqi Zhao', 'role': 'CONTACT', 'email': 'llwyh123@163.com', 'phoneExt': '0755-26692529'}], 'facility': 'Shenzhen Qianhai Shekou Free Trade Zone Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}], 'centralContacts': [{'name': 'Gang Hu, Ph.D. degree', 'role': 'CONTACT', 'email': 'hugangxa@163.com', 'phone': '86 15353731762'}, {'name': "Zhenping Xie, bachelor's degree", 'role': 'CONTACT', 'email': '2279054857@qq.com', 'phone': '86 15986696889'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Bio-gene Technology Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}