Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-08 @ 6:19 PM
Study NCT ID:
NCT04001660
Status:
UNKNOWN
Last Update Posted:
2019-06-28
First Post:
2019-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-26', 'studyFirstSubmitDate': '2019-06-24', 'studyFirstSubmitQcDate': '2019-06-26', 'lastUpdatePostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analog scale (VAS) scores', 'timeFrame': 'postoperative 6month', 'description': '1, poor; 2, fair; 3, good; 4, very good; and 5, excellent'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Subbrow Blepharoplasty;Double Eyelid Surgery； Orbicularis Oculi Muscle']}, 'descriptionModule': {'briefSummary': 'Subbrow blepharoplasty combined with double eyelid surgery excising the subbrow skin and the supratarsal upper eyelid skin, lifting and fixing the OOM flap, meanwhile restoring the natural and symmetrical appearance, is a safe, effective, and durable way for treating patients presenting with dermatochalasis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visual, lacrimal gland and eyelid functions were normal The eyes and eyebrows are aged between 35 and 65 years Informed consent was signed and approved by ethics review\n\nExclusion Criteria:\n\n* Congenital craniofacial deformity, acquired craniofacial injury Scar constitution, pregnancy Mental illness'}, 'identificationModule': {'nctId': 'NCT04001660', 'briefTitle': 'Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Subbrow Blepharoplasty Combined With Double Eyelid Surgery for Upper Eyelid Rejuvenation in Asian Women', 'orgStudyIdInfo': {'id': 'KY20192048-F-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subbrow Blepharoplasty Combined with Double Eyelid Surgery', 'description': 'An upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time.', 'interventionNames': ['Procedure: Subbrow Blepharoplasty Combined with Double Eyelid Surgery']}], 'interventions': [{'name': 'Subbrow Blepharoplasty Combined with Double Eyelid Surgery', 'type': 'PROCEDURE', 'description': 'An upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time.', 'armGroupLabels': ['Subbrow Blepharoplasty Combined with Double Eyelid Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Baoqiang Song', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}