Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-01-02 @ 4:04 AM
Study NCT ID:
NCT07079657
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thulium Laser and Growth Factors for Androgenetic Alopecia
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-07-13', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Global Aesthetic Improvement Scale', 'timeFrame': '1 and 6 months post-treatment', 'description': 'scale from 0 (very much improved) to 4 (worse)'}, {'measure': 'Hair density', 'timeFrame': 'at baseline, and 1 and 6 months post-treatment', 'description': 'measurement of hair density before and after treatment'}, {'measure': 'hair thickness', 'timeFrame': 'at baseline, and 1 and 6 months post-treatment', 'description': 'hair thickness before and after treatment'}], 'secondaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'Periprocedural', 'description': 'pain intensity during treatment using a numeric rating scale from 0 (no pain) to 10 (unbearable pain)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia (AGA)']}, 'descriptionModule': {'briefSummary': 'Androgenetic alopecia (AGA) is a common cause of hair loss worldwide. It mainly affects the frontal and parietal regions of the scalp in up to 70 % of men and 40 % of women and has a significant negative psychological and emotional impact on those affected.\n\nVarious therapies are currently approved for the treatment of AGA in men and women, including topical minoxidil, topical or systemic finasteride, platelet-rich plasma and hair transplantation. In addition to these pharmacological and surgical interventions, laser therapies including thulium laser with growth factors have gained popularity.\n\nDespite the clinical use of the thulium laser with growth factors in combination with LED phototherapy, there are only a few studies to date that have adequately investigated the objective and patient-side benefits of this therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 and over\n* Good general health, no relevant previous illnesses\n* Presence of an AGA\n* Cognitive ability and willingness to give consent (informed consent)\n* Be willing and able to attend follow-up visits\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Pregnant or breastfeeding women\n* Scarring alopecia, alopecia due to dermatoses (e.g. lichen ruber, lupus erythemodes,...), alopecia due to chemical or physical noxae, and other non-AGAs\n* Significant scarring of the region to be treated\n* Significant open wounds or lesions in the region to be treated\n* Metallic implants in the head region\n* Mental illnesses (psychoses, body perception disorders)\n* Use of isotretinoin or other retinoids, psychotropic drugs, coumarins or heparins in the last 2 weeks\n* Resurfacing (fractional, ablative, non-ablative) of the affected region \\< 2 months before and during the study period\n* Tendency to excessive scarring\n* Lack of informed consent and/or data protection declarations'}, 'identificationModule': {'nctId': 'NCT07079657', 'briefTitle': 'Thulium Laser and Growth Factors for Androgenetic Alopecia', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Thulium Laser and Growth Factors for Androgenetic Alopecia - a Prospective, Clinical Study', 'orgStudyIdInfo': {'id': '04-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Thulium laser + growth factor serum + LED', 'description': 'Thulium laser + growth factor serum + LED', 'interventionNames': ['Procedure: Thulium laser + growth factor serum + LED']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thulium laser + growth factor serum', 'description': 'Thulium laser + growth factor serum', 'interventionNames': ['Procedure: Thulium laser + growth factor serum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thulium laser', 'description': 'Thulium laser', 'interventionNames': ['Procedure: Thulium laser']}], 'interventions': [{'name': 'Thulium laser + growth factor serum + LED', 'type': 'PROCEDURE', 'description': '3 sessions at intervals of 6 weeks', 'armGroupLabels': ['Thulium laser + growth factor serum + LED']}, {'name': 'Thulium laser + growth factor serum', 'type': 'PROCEDURE', 'description': '3 sessions at intervals of 6 weeks', 'armGroupLabels': ['Thulium laser + growth factor serum']}, {'name': 'Thulium laser', 'type': 'PROCEDURE', 'description': '3 sessions at intervals of 6 weeks', 'armGroupLabels': ['Thulium laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Lynhda Nguyen, Dr. med.', 'role': 'CONTACT', 'email': 'l.nguyen@uke.de', 'phone': '+49 (0)40 7410 54289'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Lynhda Nguyen, Dr. med.', 'role': 'CONTACT', 'email': 'l.nguyen@uke.de', 'phone': '+49 (0)40 7410 54289'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Lynhda Nguyen', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}