Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-01-13 @ 7:48 AM
Study NCT ID:
NCT02780258
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Restylane Silk for Photoaged Thinned Hands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2016-05-19', 'studyFirstSubmitQcDate': '2016-05-20', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in photoaged thinning of the treatment area as measured by the 5 point hand grading scale', 'timeFrame': 'Baseline, 1month, 3months, 6 months'}]}, 'conditionsModule': {'conditions': ['Photoaged Thinning of the Hands']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of Restylane Silk for photoaged thinned hands'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female volunteer\n* Aged from 40-70 years on the day of screening\n* No known medical conditions that may interfere with study participation\n* Moderate to very severe Photoaged thinning of the hands based on the 5-point hand grading scale\n* Willingness to not use any products on their hands for the duration of the study\n* Read, understand, and sign informed consent forms\n* Willingness to sign photography release form\n* Willing and able to comply with all follow-up requirements\n* Willingness to undergo Restylane Silk injections to one hand\n\nExclusion Criteria:\n\n* Any significant skin disease at treatment area\n* Any medical condition which could interfere with the treatment\n* Inability or unwillingness to follow the treatment schedule\n* Inability or unwillingness to sign the informed consent\n* History of poor wound healing\n* History of keloid formation\n* History of HIV, hepatitis, immuno-compromised\n* Pregnant or lactating\n* Previous use of deep chemical peels on the treatment area\n* Previous injections of Restylane Silk to the hands\n* Known hypersensitivity to Restylane Silk or any of its ingredients\n* Previous laser or light based treatments to the treatment area 6 months prior to the screening visit'}, 'identificationModule': {'nctId': 'NCT02780258', 'briefTitle': 'Restylane Silk for Photoaged Thinned Hands', 'organization': {'class': 'OTHER', 'fullName': 'Skin Laser & Surgery Specialists'}, 'officialTitle': 'Restylane Silk for Photoaged Thinned Hands', 'orgStudyIdInfo': {'id': 'RESTHANDS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Restylane Silk Treated Hand', 'description': 'The dorsal aspect of one hand will be injected with Restylane Silk.', 'interventionNames': ['Device: Restylane Silk']}, {'type': 'NO_INTERVENTION', 'label': 'Control Hand', 'description': 'The dorsal aspect of the hand that is not treated will be used for baseline comparison.'}], 'interventions': [{'name': 'Restylane Silk', 'type': 'DEVICE', 'armGroupLabels': ['Restylane Silk Treated Hand']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skin Laser & Surgery Specialists', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'David J. Goldberg, MD, JD', 'investigatorFullName': 'David J. Goldberg, MD', 'investigatorAffiliation': 'Skin Laser & Surgery Specialists'}}}}