Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-07 @ 5:34 AM
Study NCT ID:
NCT02347969
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2015-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C413183', 'term': '1,4-bis(3-carboxy-4-hydroxyphenylethenyl)-benzene'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2015-01-16', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin radiance: clinical scoring', 'timeFrame': 'At 0 week and 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Subject self-assessments', 'timeFrame': 'At 0 week and 8 weeks', 'description': 'Subjects will evaluate the radiance of their complexion by self-assessment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antioxidant', 'skin radiance', 'skin elasticity', 'skin firmness', 'skin hydration'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The main objective of this trial is to evaluate the effect of the daily dose of X34 dietary supplement on skin radiance (clinical assessment) for 8 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female volunteers:\n* Age: 40-70 years\n* Who have a dull complexion evaluated by clinical scoring\n* Phototype II to IV (annex 5)\n* Non-smoking or smoking less than 5 cigarettes per day\n* Did not change her eating habits, within one month before the start of the study and agreeing not change during the study\n* With no history of facial skin care (peeling, mask…) 15 days before the beginning of the study and agreeing not to perform during the study\n* Volunteers accepting not changing their local treatment on face\n* Who agree to avoid UV exposure (sun or tanning booth) during the study\n* Who have a fixed address and are entitled to Social Security or a similar National Insurance scheme\n* Who sign a written informed consent\n\nExclusion Criteria:\n\n* Pregnant, nursing, or intending to become pregnant in the course of the study\n* With a history of allergy or hypersensitivity to the products or one of their components\n* Having use oral nutritional supplements and/or vitamin supplementation less than one month before and/or refusing not consuming nutritional supplement during the study\n* Having used cosmetics and/or topical preparations containing ingredients claiming efficacy on skin radiance less than 15 days before and/or during the study\n* With a dermatosis, systemic disease or treatment susceptible to interfere with the evolution of the parameters of the study or with taking the nutritional supplement\n* Participation in another clinical trial evaluating skin radiance during the last month before the study\n* Participation in another clinical trial or volunteers being in the exclusion phase of such a trial, thus being unable to participate in any other one\n* Who have forfeited their freedom by judiciary decision or are deemed legally incompetent\n* Having perceived more than 4500 € as indemnification fees for participation in clinical trials during the preceding 12 months (including participation in this clinical trial)\n* Unable to comply with the protocol constraints\n* Who cannot be contacted by phone rapidly'}, 'identificationModule': {'nctId': 'NCT02347969', 'briefTitle': 'Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion', 'nctIdAliases': ['NCT02352415'], 'organization': {'class': 'OTHER', 'fullName': 'Nutratech Conseils'}, 'officialTitle': 'Evaluation of the Effect of the Dietary Supplement X34 on Skin Radiance of Healthy Volunteers With Dull Complexion', 'orgStudyIdInfo': {'id': 'DE-87'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'X34', 'description': 'Arm supplemented with X34', 'interventionNames': ['Dietary Supplement: X34']}], 'interventions': [{'name': 'X34', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Dietary supplement named X34', 'armGroupLabels': ['X34']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutratech Conseils', 'class': 'OTHER'}, 'collaborators': [{'name': 'Research and Studies Center on the Integument (CERT)', 'class': 'UNKNOWN'}, {'name': 'University of Franche-Comté', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, {'name': 'Clinical Investigation Center (CIC) INSERM 1431', 'class': 'UNKNOWN'}, {'name': 'INSERM UMR1098', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}