Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-14 @ 9:00 AM
Study NCT ID:
NCT07271212
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scalp Care Efficacy Evaluation for Premium Revitalizing Elixir
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': 'D007334', 'term': 'Insulin-Like Growth Factor I'}, {'id': 'C526146', 'term': 'Centella asiatica extract'}], 'ancestors': [{'id': 'D013002', 'term': 'Somatomedins'}, {'id': 'D000096764', 'term': 'Insulin-Like Peptides'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sebum Content', 'timeFrame': 'Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)', 'description': 'Assess oil levels on the scalp at standardized scalp sites (left, right, and vertex). Measured with C+K Multi Probe Adaptor MPA580 system using the Sebumeter® SM815 probe based on the grease spot photometry method with the sebum measurement cassette tape.'}, {'measure': 'Hair length', 'timeFrame': 'Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)', 'description': 'Hair length (cm): Measured manually with ruler at standardized scalp sites (left, right, and vertex).'}, {'measure': 'Hair density', 'timeFrame': 'Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)', 'description': 'Hair density (number of hairs/cm-square): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).'}, {'measure': 'Hair thickness', 'timeFrame': 'Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0 as baseline)', 'description': 'Hair thickness (micrometers): Assessed with the ScalpX Intelligent Scalp Diagnostic System with digital microscopy at standardized scalp sites (left, right, and vertex).'}, {'measure': 'Hair loss', 'timeFrame': 'Assessment conducted every 14 days from Day 0 to Day 56 (including Day 0)', 'description': "Hair loss: Assessed by the standardized hair combing test by counting the number of hairs shed after the participants' hair was combed over a clean surface for 60 strokes."}], 'secondaryOutcomes': [{'measure': 'Participant self-assessment', 'timeFrame': 'Day 56 (End of the study period)', 'description': 'Participants will be asked to fill out an assessment form with score from 0 to 4 for each of the hair and scalp condition evaluated.'}, {'measure': 'Hair specialist assessment', 'timeFrame': 'Day 56 (End of the study)', 'description': 'A hair specialist will assess the hair and scalp condition of the participant and assign a score from 0 to 4 for each of the evaluated items as well as assign a score of Global Aesthetic Improvement Scale (GAIS) from -1 to 3.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scalp care', 'Hair loss', 'Alopecia', 'Skin texture', 'Sebum measurement', 'Hair thinning', 'Scalp condition', 'Extracellular vesicles', 'Growth factors', 'Centella asiatica', 'Ginger', 'Cosmetics', 'hair density', 'Product formulation'], 'conditions': ['Scalp Health', 'Hair Condition', 'Hair Loss', 'Alopecia', 'Sebum Production', 'Hair Health', 'Hair Thinning']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the efficacy of the Premium Revitalizing Elixir on human scalp skin. A total of 60 healthy adults, aged 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning will be recruited and randomly assigned into five groups receiving different formulations. Participants will use the product once daily for 56 days, and their scalp conditions will be assessed through skin texture tests at multiple time points. Key parameters such as sebum content, overall hair loss, hair density, scalp condition, and hair length will be measured. A self-assessment and assessment by a hair specialist on hair and scalp condition will also be provided at the end of the study (Day 56).', 'detailedDescription': 'This is a prospective, randomized, double-blinded, and placebo-controlled study to investigate the effects of Premium Scalp Revitalizing Essence on changes in the skin texture of human scalp skin.\n\nThis study aims to enroll 60 healthy adults aged from 18 to 60 with alopecia, baldness, or self-identified with symptoms of hair thinning.\n\nInclusion criteria include healthy adults defined as individuals without chronic diseases, significant illnesses (including cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant), or allergic constitutions, and who are not currently taking any medication or using any scalp care products.\n\nExclusion criteria include individuals who are pregnant or breastfeeding, as well as males or females with chronic diseases, significant illnesses, or allergic constitutions, currently using scalp care products, students or employees affiliated with the principal investigator, individuals with scalp wounds, those who have participated in cosmetic product testing, and those who have undergone scalp aesthetic treatments within the past three months.\n\nThe participants will be randomly assigned into five groups, with 12 individuals in each group. Group 1 uses Placebo (Base formula without caffeine and panthenol); Group 2 uses the Base formula (Control with 0.1% caffeine and panthenol); Group 3 uses Base + IGF-1 \\& FGF-7; Group 4 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles; Group 5 uses Base + Centella asiatica extracellular vesicles + Ginger-derived extracellular vesicles + IGF-1 \\& FGF-7. Before using the test product, all 60 participants undergo the first scalp skin texture test. After 14 days of using the test product, a second scalp skin texture test is conducted; after 28 days of use, a third test is performed; after 42 days of use, a fourth test is conducted; and after 56 days of use, a fifth test is carried out. The scalp skin texture tests include measurements of skin (1) sebum content, (2) overall hair loss, (3) hair density, (4) scalp condition, (5) hair length, and other parameters. The Sebumeter® SM815 probe of the MPA580 device and the ScalpX Intelligent Scalp Diagnostic System will be used to measure the parameters of the study. On Day 56, the participants will be asked to fill out a self-assessment form and a hair specialist will also assess the hair and scalp condition at the end of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults of any gender from the age of 18 to 60 years (inclusive).\n* Having symptoms of alopecia, baldness, or self-identified with hair thinning.\n* Absence of chronic diseases, major illnesses, or allergies.\n* Major illnesses include cancer, post-stroke disorders, paralysis, acute myocardial infarction, coronary artery bypass surgery, end-stage renal disease, and major organ transplant or hematopoietic stem cell transplant\n\nExclusion Criteria:\n\n* Currently taking any medication or using any scalp care products\n* Pregnant or breastfeeding\n* Chronic diseases, significant illnesses, or allergic constitutions\n* Currently using scalp care products\n* Students or employees affiliated with the principal investigator,\n* Individuals with scalp wounds\n* Participated in cosmetic product testing\n* Undergone scalp aesthetic treatments within the past three months.'}, 'identificationModule': {'nctId': 'NCT07271212', 'briefTitle': 'Scalp Care Efficacy Evaluation for Premium Revitalizing Elixir', 'organization': {'class': 'OTHER', 'fullName': 'Hungkuang University'}, 'officialTitle': 'Evaluation of the Scalp Skin Care Effects of Premium Revitalizing Elixir', 'orgStudyIdInfo': {'id': '25-090-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group 1: Placebo control', 'description': 'Base formula without caffeine and panthenol', 'interventionNames': ['Other: Placebo control']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Base formula only', 'description': 'Base formula consisting of active ingredients 0.1% caffeine and panthenol (vitamin B5).', 'interventionNames': ['Other: Base formula only']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Base formula plus IGF-1 & FGF-7.', 'description': 'Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7)', 'interventionNames': ['Other: Base formula plus IGF-1 and FGF-7']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles', 'description': 'Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles', 'interventionNames': ['Other: Base formula plus Centella asiatica and ginger extracellular vesicles']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7.', 'description': 'Base formula plus Centella asiatica and ginger (Zingiber officinale) extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7).', 'interventionNames': ['Other: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7']}], 'interventions': [{'name': 'Placebo control', 'type': 'OTHER', 'description': 'Placebo control (base formula without caffeine and panthenol). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.', 'armGroupLabels': ['Group 1: Placebo control']}, {'name': 'Base formula only', 'type': 'OTHER', 'description': 'Base formula consisting of active ingredients 0.1% caffeine and panthenol. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.', 'armGroupLabels': ['Group 2: Base formula only']}, {'name': 'Base formula plus IGF-1 and FGF-7', 'type': 'OTHER', 'description': 'Base formula plus insulin growth factor 1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.', 'armGroupLabels': ['Group 3: Base formula plus IGF-1 & FGF-7.']}, {'name': 'Base formula plus Centella asiatica and ginger extracellular vesicles', 'type': 'OTHER', 'description': 'Base formula plus Centella asiatica and ginger extracellular vesicles. Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.', 'armGroupLabels': ['Group 4: Base formula plus Centella asiatica and ginger extracellular vesicles']}, {'name': 'Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7', 'type': 'OTHER', 'description': 'Base formula plus Centella asiatica and ginger extracellular vesicles, insulin growth factor-1 (IGF-1) and fibroblast growth factor-7 (FGF-7). Applied 1mL evenly to the scalp once daily after hair wash for 56 consecutive days.', 'armGroupLabels': ['Group 5: Base formula plus Centella asiatica and ginger extracellular vesicles, IGF-1 & FGF-7.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '433304', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Hungkuang University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hungkuang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Schweitzer Biotech Company', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President', 'investigatorFullName': 'Tsong-Min Chang', 'investigatorAffiliation': 'Hungkuang University'}}}}