Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-01 @ 6:44 AM
Study NCT ID:
NCT06028295
Status:
COMPLETED
Last Update Posted:
2024-04-01
First Post:
2023-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Two Dietary Supplements on Hair Loss and Hair Aspect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-08-31', 'lastUpdatePostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Telogen hair proportion', 'timeFrame': 'Baseline', 'description': 'Phototrichogram'}, {'measure': 'Telogen hair proportion', 'timeFrame': '56 days', 'description': 'Phototrichogram'}, {'measure': 'Telogen hair proportion', 'timeFrame': '84 days', 'description': 'Phototrichogram'}], 'secondaryOutcomes': [{'measure': 'Anagen hair proportion', 'timeFrame': 'Baseline', 'description': 'Phototrichogram'}, {'measure': 'Anagen hair proportion', 'timeFrame': '56 days', 'description': 'Phototrichogram'}, {'measure': 'Anagen hair proportion', 'timeFrame': '84 days', 'description': 'Phototrichogram'}, {'measure': 'Hair growth', 'timeFrame': '84 days', 'description': 'Hair length after shaving'}, {'measure': 'Hair elasticity', 'timeFrame': 'Baseline', 'description': 'Hair elongation using dynamometer'}, {'measure': 'Hair elasticity', 'timeFrame': '84 days', 'description': 'Hair elongation using dynamometer'}, {'measure': 'Hair loss', 'timeFrame': 'Baseline', 'description': 'Pull test'}, {'measure': 'Hair loss', 'timeFrame': '56 days', 'description': 'Pull test'}, {'measure': 'Hair loss', 'timeFrame': '84 days', 'description': 'Pull test'}, {'measure': 'Self-assessment of product efficacy', 'timeFrame': '84 days', 'description': 'Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The study is aimed to assess the efficacy of two dietary supplements composed of a Wheat Polar Lipid Complex (WPLC) in oil or powder form in reducing hair loss and improving hair aspect.', 'detailedDescription': 'A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female subjects aged between 18 and 65 years old with all hair type showing diffuse and temporary hair shedding with a proportion of hair in telogen phase \\>15%. The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 56 and 84 days of products consumption.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n* Healthy female subjects,\n* Caucasian ethnicity,\n* Age between 18 and 65 years old (extremes included),\n* All hair type included,\n* Subject showing acute hair shedding (duration less than 6 months) due to fatigue, seasonal change, deficiency of vitamins and minerals, stress, change or imbalance of normal daily routing, or emotional stress,\n* Women showing a proportion of hair in telogen phase \\> 15%,\n* Subjects complaining brittle and thin hair,\n* Subjects who stopped any anti hair loss treatment at least 3 months prior the study,\n* Subjects agreeing not to take any treatment (oral or topic) able to interfere with the hair growth, diameter or fall during the whole study duration,\n* Subjects who have not been involved in any other similar study in the last 3 months,\n* Subjects registered with health social security or health social insurance, Subjects able to understand the language used in the investigation center and the information given\n* Subjects able to comply with the protocol and follow protocol's constraints and specific requirements\n* Willingness to use the same products for hair care during all the study period\n* Willingness not to cut hair for all the study length.\n* Subjects having signed their written Informed Consent form (ICF) for their participation in the study and a photograph authorization.\n\nExclusion Criteria:\n\n* Subject does not meet the inclusion criteria,\n* Subject is taking part or planning to participate to another clinical study in the same or in another investigation centre,\n* Subject is deprived of freedom by administrative or legal decision or under guardianship,\n* Subject is admitted in a sanitary or social facilities,\n* Subject is planning an hospitalization during the study,\n* Subject has participated in another clinical study with anti-hair loss product or treatment within the last 3 months before the inclusion visit,\n* Subject is breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential),\n* Subject has started or changed oestrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study,\n* Subject having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements,\n* Subject is in course of a long-treatment or intending to have one considered by the Investigator liable to interfere with the study data or incompatible with the study requirements,\n* Subject having a skin/scalp condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements,\n* Subject having personal history of cosmetic, drug, domestic products or food supplements allergy,\n* Subject having food disorders,\n* Subject who has any other hair disorder or hair disease (female pattern hair loss, any type of alopecia...),\n* Subject having excessive and/or fluctuating hair shedding for more than 6 months,\n* History or clinical signs of hyperandrogenemia (menstrual cycle \\>35 days and hirsutism and acne),\n* Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit: retinoids, anti-mitotic, cytotoxic drugs other than antineoplastic, anti-androgens (spironolactone, flutamide), androgens, anti-epileptic agents, interferon alpha,\n* Systemic or local androgenetic alopecia treatment or product, taken or applied (Minoxidil, Aminexil, Finasteride, Dutasteride, cosmetic solution or capsules with vitamin B, zinc, caffeine...) for more than 4 consecutive weeks during the last 24 weeks before the inclusion visit,\n* Any other topical treatment applied on the scalp (non-steroidal anti-inflammatory, ketoconazole...) within the last 2 weeks before the inclusion visit,\n* No hair wash in the 48 hours before each visit,\n* Any following hair care within the last 2 weeks before each visit: dandruff shampoo, antifungal shampoo, dyeing, bleaching, perm,\n* Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam...),\n* Radiotherapy, chemotherapy at any time,\n* Scalp surgery (hair transplants, laser) at any time."}, 'identificationModule': {'nctId': 'NCT06028295', 'briefTitle': 'Evaluation of the Efficacy of Two Dietary Supplements on Hair Loss and Hair Aspect', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seppic'}, 'officialTitle': 'Clinical-instrumental Evaluation of the Efficacy of Two Dietary Supplements Claiming Anti-hair Loss Properties and Hair Strength Improvement. A Double-blind, Randomized, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'IT0003622/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wheat Polar Lipid Complex Oil', 'description': 'Dietary supplement - Wheat Polar Lipid Complex (Oil)', 'interventionNames': ['Dietary Supplement: Wheat Polar Lipid Complex Oil']}, {'type': 'EXPERIMENTAL', 'label': 'Wheat Polar Lipid Complex Powder', 'description': 'Dietary supplement - Wheat Polar Lipid Complex (Powder)', 'interventionNames': ['Dietary Supplement: Wheat Polar Lipid Complex Powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Dietary supplement - Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Wheat Polar Lipid Complex Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The study foresees the intake of 2 capsules per day during 84 days', 'armGroupLabels': ['Wheat Polar Lipid Complex Oil']}, {'name': 'Wheat Polar Lipid Complex Powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The study foresees the intake of 2 capsules per day during 84 days', 'armGroupLabels': ['Wheat Polar Lipid Complex Powder']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The study foresees the intake of 2 capsules per day during 84 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20024', 'city': 'Milan', 'country': 'Italy', 'facility': 'Complife Italia srl', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'Ileana De Ponti', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Complife Italia S.r.l'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seppic', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}