Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-01 @ 6:07 AM
Study NCT ID:
NCT01321268
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2011-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of a Dietary Supplement in Females With Cellulite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071697', 'term': 'Cellulite'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D000077185', 'term': 'Resveratrol'}, {'id': 'D000077276', 'term': 'Lycopene'}, {'id': 'D019207', 'term': 'beta Carotene'}, {'id': 'D014975', 'term': 'Lutein'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000081225', 'term': 'Stilbestrols'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D059808', 'term': 'Polyphenols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D024341', 'term': 'Xanthophylls'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'sponsor stopped study due to recruitment problems', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2011-03-10', 'studyFirstSubmitQcDate': '2011-03-22', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical biochemistry (hematology, blood chemistry, blood coagulation)', 'timeFrame': '6 months', 'description': 'change in clinical biochemistry at 6 months vs baseline'}, {'measure': 'vital signs', 'timeFrame': '6 months', 'description': 'change in clinical examination at 6 months vs baseline'}, {'measure': 'adverse events and tolerability', 'timeFrame': '6 months', 'description': 'change in number of persons with adverse events at 6 months vs baseline'}], 'secondaryOutcomes': [{'measure': 'cellulite severity', 'timeFrame': 'Day 1, 7, 30, 60, 90, 120, 150, 180', 'description': 'change in cellulite severity grading according to the cellulite severity scale (CSS)(visual morphological aspects) within repeated measurements'}, {'measure': 'Thigh circumference', 'timeFrame': 'Day 1, 7, 30, 60, 90, 120, 150, 180', 'description': 'Change in thigh circumferences below gluteus fold within repeated measurements, Change in thigh circumferences above the upper part of the knee within repeated measurements'}, {'measure': 'Digital photography', 'timeFrame': 'Day 1, Day 90, Day 180', 'description': 'Change in digital photography Day 90 vs Day 1 Change in digital photography Dag 180 vs Day 1'}, {'measure': 'Ultrasound sonography', 'timeFrame': 'Day 1, Day 90 and Day 180', 'description': 'Change in ultrasound Day 180 vs Day 1, Change in ultrasound Day 90 vs Day 1'}, {'measure': 'Magnetic resonance', 'timeFrame': 'Day 1 and Day 180', 'description': 'change in adipose tissue Day 180 vs Day 1'}, {'measure': 'satisfaction questionnaire', 'timeFrame': 'Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180', 'description': 'Improvement in patient satisfaction'}, {'measure': 'dermatology life quality index', 'timeFrame': 'day 1, 30, 60, 90, 120, 150, 180', 'description': 'Improvements in the parameters of quality of life'}, {'measure': 'celluquol questionnaire', 'timeFrame': 'day 1, 30, 60, 90, 120, 150, 180', 'description': 'each question in repeated measurements'}, {'measure': 'cutometry', 'timeFrame': 'day 1, 90, 180', 'description': 'change in skin elasticity from day 180 to day 1, change in skin elasticity from day 90 to day 1'}, {'measure': 'corneometry', 'timeFrame': 'day 1, 90, 180', 'description': 'change in skin hydration day 180 vs day 1, change in skin hydration day 90 vs day 1'}, {'measure': 'skin profilometry', 'timeFrame': 'day 1, 90, 180', 'description': 'change in skin topography day 180 vs day 1, change in skin topography day 90 vs day 1'}, {'measure': 'liquichip analysis', 'timeFrame': 'day 1, day 180', 'description': 'change in inflammatory markers day 180 vs day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['orange peel skin', 'cellulite'], 'conditions': ['Cellulite (Orange Peel Skin)']}, 'descriptionModule': {'briefSummary': 'To investigate the safety and efficacy of a dietary supplement on cellulite alleviation, fat deposits and quality of life.', 'detailedDescription': 'The study will be conducted as a single centre, randomized, double-blind, controlled, parallel group study with healthy female volunteers, aged 18-45 years of age, with skin phototypes I to VI and a clinical diagnosis of cellulite on buttocks (at least score 6 at Cellulite Severity Scale (CSS)).\n\nThe study will take 24 weeks (6 months) per subject. There will be one previsit during the screening phase and 8 visits per subject during the treatment phase.\n\nSafety and efficacy variables will be performed monthly.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female volunteers\n* Age between 18 and 45 years at Day 01 of the study\n* Body mass index (BMI) from 18.5 -24.9\n* All Fitzpatrick skin types\n* CSS score of at least 6\n* Normal eating habits (no vegetarians or vegans)\n* Written informed consent\n\nExclusion Criteria:\n\n* Menopause and pre-menopause\n* Smoking\n* Pregnant women or women intending to become pregnant during study\n* Lactation period\n* Any kind of dermatological conditions\n* Vegetarians or vegans\n* Any kind of hepatitis, including any alteration in transaminases\n* Use of illicit drugs\n* Other surgical or internal diseases e.g. a metabolic or endocrine disease that may affect the outcome of the study (e.g. diabetes, liver diseases, kidney disorders) or having a history of medical or surgical events that may significantly affect the study outcome including any cardiovascular disease, skin disease, hypertension (\\>160/95 mm Hg at repeated measurements)\n* Existence of scars and/or pigmentation in measurement areas (thighs and buttocks), which can influence study measurements\n* Participation in any other clinical trial including blood sampling and/or administration or substances up to 30 days before Day 01 of this study\n* Any prior aesthetic surgery (Liposuction, Subcision®), 3 months before the study, that may interfere with results\n* Any other prior anti-cellulite treatment or body measures treatment, 30 days prior to the study\n* Participation in any other non-invasive clinical trial up to 30 days before Day 01 of this study, including blood sampling\n* Recent blood or plasmapherese donation (less than 1 month prior to Day 01 of the study)\n* Under medical treatment for a skin disease in the past and/or present with a therapy, which may influence the results of the study (systemic steroids or antibiotics, local steroids or topical immunomodulators during the last 3 months\n* Use of sun beds or self-tanning products or sun exposure for one month before and during study\n* Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner\n* Subjects intending to initiate any intensive sports\n* Every other condition that the investigator might consider to involve a risk for the study subject.'}, 'identificationModule': {'nctId': 'NCT01321268', 'briefTitle': 'Safety and Efficacy of a Dietary Supplement in Females With Cellulite', 'organization': {'class': 'INDUSTRY', 'fullName': 'DSM Nutritional Products, Inc.'}, 'officialTitle': 'Safety and Efficacy of an Antioxidant Based Dietary Supplement With PUFAs in Healthy Female Volunteers With Cellulite (Orange Peel Skin)', 'orgStudyIdInfo': {'id': '2009-11-03-CEL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dietary supplement for cellulite', 'description': 'PUFA, resveratrol, lycopene, beta carotene, lutein', 'interventionNames': ['Dietary Supplement: dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Vitamin E', 'interventionNames': ['Dietary Supplement: Viatmin E']}], 'interventions': [{'name': 'dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral, twice daily in morning and evening for 6 months', 'armGroupLabels': ['dietary supplement for cellulite']}, {'name': 'Viatmin E', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral, twice daily in morning and evening for 6 months', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'CBED: Brazilian Center for Studies in dermatology', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Doris M Hexsel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brazilian Center for Studies in Dermatology (CBED)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DSM Nutritional Products, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}