Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT03394235
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2018-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter
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': 'D053844', 'term': 'Lasers, Solid-State'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a pilot study. We plan to enroll 15 participants who requires to do hair transplantation or normal participants who are eligible for the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-06', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the changes in hair density at the treated sites.', 'timeFrame': '24 weeks', 'description': 'Evaluate changes in hair density at the treated sites following long-pulsed, 1064 Nd-YAG laser sessions every 8 weeks or until the treatment endpoint is reached before or at 24 weeks.'}], 'secondaryOutcomes': [{'measure': 'Evaluate the changes in hair diameter at the treated sites.', 'timeFrame': '24 weeks', 'description': 'Evaluate the changes in hair diameter at the treated sites following long-pulsed, 1064 Nd-YAG laser sessions every 8 weeks or until the treatment endpoint is reached before or at 24 weeks.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hair transplant', 'hairline', 'laser hair removal'], 'conditions': ['Androgenetic Alopecia', 'Hair Loss/Baldness']}, 'descriptionModule': {'briefSummary': 'This study evaluates the optimizing parameters of long pulse Nd:YAG Laser for reducing the size of hair shaft diameter of the donor for hair transplantation. All participants will receive long-pulsed Nd-YAG laser treatments with three different parameters at the occipital area.', 'detailedDescription': 'Since the beginning of hair transplantation era, hair transplant technique has been greatly improved to achieve the best natural looking of hairline and hair density. Most Asians tend to have large size of hair shaft at the donor area, which often cause unnatural look of the hairline at the frontal area after hair transplantation due to the contrast between the transplanted hair and the original hair.\n\nThe idea of reducing the size of the hair shaft in the certain part of donor area before being transplanted to the frontal hairline becomes appealing. This transection is being practiced extensively in the field of cosmetic medicine by using long-pulsed Neodymium-Doped:Yttrium Aluminum Gamet (Nd:YAG), a laser treatment for permanent hair removal and vascular lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women, aged 25-60 years with AGA or healthy\n* Completed informed consent form\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Acute infection on the scalp or any systemic infection\n* Immunocompromised host\n* Chronic wasting diseases\n* Use of any medications which may affect hair loss such as anticoagulants, anti-hypertensive, hormones, anticonvulsants, retinoid, mood stabilizers and antidepressants\n* Unstable medical problems which may affect hair loss such as thyroid diseases, autoimmune diseases, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, congestive heart failure, cerebrovascular accident and psychiatric problems\n* Hair thinning at the occipital area'}, 'identificationModule': {'nctId': 'NCT03394235', 'briefTitle': 'Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Dermatology, Thailand'}, 'officialTitle': 'Optimizing Parameters for Long-pulsed Nd:YAG Laser for Reducing Hair Shaft Diameter at the Donor Area for Hair Transplantation', 'orgStudyIdInfo': {'id': '007/2561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-pulsed, 1064nm Nd-YAG laser', 'description': 'All participants will receive long-pulsed, 1064nm Nd-YAG laser treatments with three different parameters at the occipital area.', 'interventionNames': ['Device: Long-pulsed, 1064nm Nd-YAG laser']}], 'interventions': [{'name': 'Long-pulsed, 1064nm Nd-YAG laser', 'type': 'DEVICE', 'description': 'This long-pulsed Nd-YAG laser is commonly used for laser hair removal and vascular lesions, but in this study it is used to reduce the size of the hair shaft at the occipital area.', 'armGroupLabels': ['Long-pulsed, 1064nm Nd-YAG laser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Institute of Dermatology', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Chinmanat Tangjaturonrusamee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Dermatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Individual participant data is not stated in participants' informed consent."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Dermatology, Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}