Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT03685656
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2018-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-19', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-09-24', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': '8 weeks', 'description': 'Measure of the waist circumference using a measuring tape.'}], 'secondaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': '2 weeks', 'description': 'Measure of the waist circumference using a measuring tape.'}, {'measure': 'Abdominal circumference', 'timeFrame': '2 and 8 weeks', 'description': 'Measure of the abdominal circumference (at the level of the navel) using a measuring tape.'}, {'measure': 'Hip circumference', 'timeFrame': '2 and 8 weeks', 'description': 'Measure of the hip circumference using a measuring tape.'}, {'measure': 'Thigh circumference', 'timeFrame': '2 and 8 weeks', 'description': 'Measure of thigh circumference using a measuring tape.'}, {'measure': 'Abdominal skinfold using a Harpenden skinfold caliper', 'timeFrame': '2 and 8 weeks', 'description': 'Measure of the abdominal skinfold using a Harpenden skinfold caliper'}, {'measure': 'Cellulite', 'timeFrame': '2 and 8 weeks', 'description': 'Scoring of cellulite in the thighs using a photography scale Scale: 8 photographies - Grade 0 to Grade 8; Hiher the grade is, more there is cellulite.'}, {'measure': 'Elasticity and firmness of the abdominal skin', 'timeFrame': '2 and 8 weeks', 'description': 'Measure of the elasticity and firmness of the abdominal skin using a cutometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overweight', 'Obesity', 'Slimming gel', 'Cosmetic product', 'Waist circumference', 'Thigh circumference'], 'conditions': ['Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'Overweight and obesity is defined, according to the World Health Organization (WHO), by abnormal or excessive accumulation of adipose or fatty tissue that may be harmful to health.\n\nOverweight and obesity are therefore important determinants of health, which expose people to many pathologies whose consequences for individuals are not only health, but also social: stigma, prejudice, discrimination.\n\nIndeed, most overweight people have a bad image of themselves. For some people, overweight can trigger stress, malaise and disgust.\n\nTo break free from this malaise and satisfy the growing desire of women to take care of their body, many products are present in the slimming beauty market.\n\nEFFANACA3GEL is a prospective, randomized, double-blind, placebo controlled study. 208 healthy volunteers will be followed for 2 months during which they will use ANACA3 slimming gel. The aim of this study is to evaluate the effects of ANACA3 slimming gel on hip and waist circumferences.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy woman,\n* Age between 18 and 65 years,\n* Body mass index (BMI) strictly greater than 23 kg / m² and strictly less than 35 kg / m² with a stable weight (± 2 kg) for at least 3 months,\n* Stable physical activity for at least 3 months,\n* Lack of firmness in the abdomen and thighs,\n* Presenting cellulite visible in the thighs, with a score of 3 to 8 according to the photographic scale used,\n* Hormonal treatment not modified for at least 3 months,\n* informed and written consent signed.\n\nExclusion Criteria:\n\n* Pregnant or lactating woman,\n* Use of a slimming product and / or anti-cellulite (oral or topical) in the month prior to participating in the study,\n* Slimming diet during the last 3 months,\n* Special diet: low calorie diet (slimming diet and / or medication taken with or without a significant increase in physical activity over the last 3 months) or special diet (vegetarians, vegans, any intake of nutritional supplements )\n* Smoking (more than 3 cigarettes per day) and/ or addiction to alcohol,\n* Consuming more than 3 cups of coffee and / or tea per day,\n* Active evolutionary pathology or a history of cancer,\n* Under corticosteroids or any other medicinal treatment that may have an influence on water retention without therapeutic balance at the time of inclusion,\n* Antecedent of surgery for bariatric and / or aesthetic,\n* Severe eating disorders (anorexia, bulimia, binge eating, etc.),\n* Not affiliated to a Social Security scheme.'}, 'identificationModule': {'nctId': 'NCT03685656', 'briefTitle': 'Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutravalia'}, 'officialTitle': 'Randomized, Double-blind, Placebo Controlled Trial of Effect of ANACA3 Slimming Gel on Loss of Abdominal and Thigh Circumferences in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EFFANACA3GEL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANACA3', 'description': 'ANACA3 slimming gel', 'interventionNames': ['Other: Slimming gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Slimming gel contening no active ingredient', 'interventionNames': ['Other: Slimming gel placebo']}], 'interventions': [{'name': 'Slimming gel', 'type': 'OTHER', 'otherNames': ['ANACA3 Le Gel Minceur'], 'description': 'On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.', 'armGroupLabels': ['ANACA3']}, {'name': 'Slimming gel placebo', 'type': 'OTHER', 'otherNames': ['Placebo'], 'description': 'On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'GREDECO', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutravalia', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Slb Pharma', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}