Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-28 @ 2:20 AM
Study NCT ID:
NCT06146166
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-27
First Post:
2023-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of an Oral Hair Supplement on Hair Density, Growth, and Microbiome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-11-17', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hair density', 'timeFrame': '24 weeks', 'description': 'Change in hair density as measured by Trichogram based photographic analysis'}], 'secondaryOutcomes': [{'measure': 'Hair density', 'timeFrame': '4 weeks', 'description': 'Change in hair density as measured by Trichogram based photographic analysis'}, {'measure': 'Hair diameter', 'timeFrame': '24 weeks', 'description': 'Change in hair diameter and hair diameter'}, {'measure': 'Hair diameter', 'timeFrame': '4 weeks', 'description': 'Change in hair diameter and hair diameter'}, {'measure': 'Shannon diversity of hair microbiome', 'timeFrame': '24 weeks', 'description': 'Shift in Shannon diversity measure of the hair microbiome'}, {'measure': 'Hair health measured by global photographs as subjective factors graded by the investigator', 'timeFrame': '4 weeks', 'description': 'Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator'}, {'measure': 'Hair health measured by global photographs as subjective factors graded by the investigator', 'timeFrame': '24 weeks', 'description': 'Change in hair growth, density, and shine measured by global photographs as subjective factors graded by the investigator'}, {'measure': 'Self-perception of hair', 'timeFrame': '4 weeks', 'description': '10-question survey based self grading of hair growth, density, and shine measured with subjective questionnaire. Answers range from Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree.'}, {'measure': 'Self-perception of hair', 'timeFrame': '24 weeks', 'description': '10-question survey based self grading of hair growth, density, and shine measured with subjective questionnaire. Answers range from Strongly Agree, Agree, Neutral, Disagree, or Strongly Disagree.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hair Thinning']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess how an oral herbal supplement influences hair density, shine, growth, and microbiome.', 'detailedDescription': 'Hair thinning and hair loss are highly prevalent conditions affecting both men and women. Various factors can contribute to hair thinning and loss, including nutrition, medications, family history, and more. Overall, hair thinning and loss have a significant impact on quality of life and patients with these concerns have limited options. For example, minoxidil, finasteride, hair transplantations, and platelet rich plasma are effective options but each are paired with their own limitations. Thus, those with hair thinning or loss are increasingly turning to natural therapies shown to improve hair density and self-perceived hair thinning.\n\nNutrition is closely related to hair health, as evidenced by hair thinning and loss that occur with malnutrition or restrictive diets. Additionally, the hair follicle microbiome has been shown to modulate inflammation that exacerbates inflammatory scalp diseases, and ultimately hair thinning and hair loss.\n\nThus, an oral supplement that addresses nutrient deficiencies and targets the hair follicle microbiome could support hair health. In this study, we examine the effects of an herbal oral supplement on hair density, shine, and growth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Men and women between the ages of 25 years old and 65 years old with self-perceived hair thinning.\n\nExclusion Criteria:\n\n* Individuals who are pregnant or breastfeeding.\n* Prisoners.\n* Adults unable to consent.\n* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.\n* Subjects with scarring forms of alopecia.\n* Any history of procedures affecting hair growth, such as transplantation\n* Any known allergy to any of the ingredients in the study product.\n* Any laser treatments for hair growth in the past 3 months\n* Use of any over-the-counter or pharmaceutical or dietary products known to affect hair growth\n* Subjects unwilling to not alter hair color or style for the duration of the study.\n* Subjects taking any hair growth oral supplementation within the past 3 months.\n* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.\n* Those who have been on an oral antibiotic within 1 month prior enrolling\n* Those who are unwilling to discontinue oral probiotics-based supplementation or supplement ingredients found in the study's oral, product 1 month prior to enrollment"}, 'identificationModule': {'nctId': 'NCT06146166', 'briefTitle': 'The Effects of an Oral Hair Supplement on Hair Density, Growth, and Microbiome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrative Skin Science and Research'}, 'officialTitle': 'Prospective, Double-Blinded, Randomized Placebo Controlled Trial of an Oral Hair Supplement on Hair Density, Growth, and Microbiome', 'orgStudyIdInfo': {'id': 'i23-10-VIDYA_HAIR_SUPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral herbal supplement', 'description': 'Oral supplement containing an herbal blend', 'interventionNames': ['Dietary Supplement: Oral herbal supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral Placebo Supplement', 'description': 'Oral placebo supplement', 'interventionNames': ['Dietary Supplement: Oral placebo supplement']}], 'interventions': [{'name': 'Oral herbal supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral supplement containing an oral blend taken once daily', 'armGroupLabels': ['Oral herbal supplement']}, {'name': 'Oral placebo supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral placebo supplement taken once daily', 'armGroupLabels': ['Oral Placebo Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrative Skin Science and Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Vidya Herbs (Sponsor)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}