Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:13 AM
Study NCT ID:
NCT07111312
Status:
COMPLETED
Last Update Posted:
2025-12-11
First Post:
2025-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008903', 'term': 'Minerals'}, {'id': 'D010936', 'term': 'Plant Extracts'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in hair density', 'timeFrame': 'From enrollment to the end of treatment at 180 days.', 'description': 'From phototrichogram on the temporoparietal area of the scalp.'}], 'secondaryOutcomes': [{'measure': 'Change in the Anagen-to-Catagen/Telogen ratio', 'timeFrame': 'From enrollment to the end of treatment at 180 days.', 'description': 'From phototrichogram on the temporoparietal area of the scalp.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Telogen Effluvium']}, 'referencesModule': {'references': [{'pmid': '41288927', 'type': 'DERIVED', 'citation': 'Bernardez C, Podlipnik S, Westgate GE, Paus R, Zamfir L, Grohmann D, Saez Moya M. Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium: A 6-Month, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2025 Nov 25. doi: 10.1007/s13555-025-01585-x. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of a drinkable nutraceutical formulated with natural, high-quality, patented, and standardized ingredients designed to support hair health through multiple biological pathways. A total of 106 premenopausal women aged 18 to 40 years and diagnosed with telogen effluvium were randomized to receive either the nutraceutical (n = 53) or placebo (n = 53). The primary endpoint was the increase in hair density from baseline versus placebo. The secondary endpoint was the change in the anagen-to-catagen/telogen (A:C/T) ratio. These parameters were assessed using phototrichoscopy and phototrichogram via TrichoScan®. The study was approved by an ethics committee and conducted by two independent board-certified dermatologists at two study sites.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-40 years\n* Sex: female\n* Telogen effluvium diagnosis with hair loss \\> 100 hairs, confirmed using validated "modified wash test"\n* Otherwise, healthy volunteers\n* Refraining from systemic, topical, oral products with similar effects to the active product\n* Signed informed consent\n* Maintenance of daily cosmetic and dietary routine\n* Availability to attend all visits\n* Compliance with all protocol requirements\n\nExclusion Criteria:\n\n* Previous use of active product\n* Participation in similar studies or usage of anti-hair loss products within the last 3 months\n* History of dermatological treatment (e.g. mesotherapy) and/or hair transplant\n* Skin or scalp diseases (e.g. psoriasis, dermatitis, alopecias)\n* Alopecia secondary to medical diseases (e.g. hypothyroidism, anemia)\n* Ongoing treatment for or diagnosis of systemic disease\n* Hormonal treatment (oral or topical contraceptives) within 6 months prior to study start\n* Known allergy or intolerance, including to any of the ingredients of the active product\n* Pregnancy, post-partum (6 months) or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07111312', 'briefTitle': 'Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olistic Research Labs S.L.'}, 'officialTitle': 'Placebo-controlled, Parallel, Randomized (1:1), Double-blind Study Over 6 Months to Evaluate the Efficacy and Safety of the Food Supplement Olistic Women.', 'orgStudyIdInfo': {'id': 'CT-OW-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Product Arm', 'interventionNames': ['Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'interventionNames': ['Other: Placebo control']}], 'interventions': [{'name': 'Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, plant extracts, amino acids, and other bioactive compounds designed to support hair growth and scalp health in women.', 'armGroupLabels': ['Active Product Arm']}, {'name': 'Placebo control', 'type': 'OTHER', 'description': 'Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile.', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Zurko-CTC', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'ClĂnica AB Derma', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olistic Research Labs S.L.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}