None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomized to receive test group or placebo. The test Group orally took 1 tablet containing 600 mg of hydrangea leaf hot water extract (active ingredient) once da
Sponsors
Cosmax Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Man and woman over the age of 19 and under the age of 60 2) Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors 3) A person who agrees not to undergo any cosmetic procedures such as perming or hair coloring, except for haircuts, during the period of the human application study 4) A person who agrees to participate in the human body application test and prepares a written consent form prior to the commencement of the human body application test
Exclusion criteria
Exclusion criteria: 1) A person currently receiving treatment for infectious diseases, including severe cardiovascular, immune, respiratory, hepatobiliary, renal and urologic, nervous, musculoskeletal, psychiatric, or skin disorders 2) A person with a history of malignant tumors within 5 years as of Visit 1 3) As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection 4) As of Visit 1, a person who has hair loss disorders such as androgenetic alopecia, alopecia areata, telogen effluvium, or cicatricial alopecia. 5) A person who plans to manage or manipulate hair using hair care devices or products during the human application study (e.g., medical devices for hair loss treatment [low-level laser therapy], LG MediHair, Wontech Hair Beam Light, scalp or hair steam packs [including salon or home care]). 6) A person who has taken oral Dutasteride or Finasteride within 6 months as of Visit 1. 7) A person who has taken medications that may affect hair growth within 3 months as of Visit 1. 8) A person who has consumed health functional foods (e.g., biotin, collagen, hydrangea leaf hot-water extract) or general foods (e.g., brewer’s yeast) that may affect the human application study within 2 weeks as of Visit 1. 9) A person who has applied topical hair growth agents, wool-derived products, or hair growth promoters for 1 month (30 days) as of Visit 1. 10) A person who has taken systemic steroids, cytotoxic agents, vasodilators, antihypertensive agents, antiepileptic agents, beta-blockers, bronchodilators, diuretics, Spironolactone, Cimetidine, Diazoxide, Cyclosporine, or Ketoconazole for 1 month (30 days) as of Visit 1. 11) A person who has applied topical steroid preparations to the scalp for 1 month (30 days) as of Visit 1. 12) A person who has consumed alcohol exceeding 40 g/day (280 g/week) for males or 20 g/day (140 g/week) for females within 1 month (30 days) as of Visit 1 13) A person with systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg as of Visit 1 (measured after stabilizing the subject for at least 10 minutes) 14) A person with uncontrolled diabetes mellitus (fasting blood glucose =140 mg/dL). 15) A person with AST (GOT), ALT (GPT), or total bilirubin levels =2 times the upper limit of normal at the test institution. 16) A person with creatinine levels =2 times the upper limit of normal at the test institution 17) A person with TSH =0.1 µIU/mL or =10 µIU/mL 18) A person who has difficulty ingesting the food for the human application study due to severe gastrointestinal disorders. 19) A person who has participated in another interventional clinical trial (including human application studies) within three (3) months as of Visit 1, or who plans to participate in another interventional clinical trial after the initiation of this human application study 20) A woman who is within 6 months postpartum as of Visit 1 21) A person who is pregnant, breastfeeding, or planning to become pregnant during the human application study 22) A person who is sensitive to or allergic to any ingredients of the food used in this human application study 23) A person who is deemed inappropriate for participation by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hair elasticity;Hair gloss;Human satisfaction survey | — |
Secondary
| Measure | Time frame |
|---|---|
| Hair density;Hair diameter;Hair root volume ;Scalp moisture ;Scalp percutaneous moisture loss;Number of hair loss;Scalp soothing;Scalp elasticity;Scalp flakes;Scalp sebum | — |
Countries
Korea, Republic of
Contacts
Public ContactInah Kim
Global Medical Research Center
Outcome results
None listed