None listed
Conditions
Interventions
Others(Functional Cosmetic) : The product name of the test product is a shampoo containing Malvae Semen extract. It is to be used once a day for 24 weeks. After thoroughly wetting the hair and scalp w
Sponsors
Semyung University Oriental Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The criteria for participants in the study were as follows: 1. Men or women aged 19 to 54 years diagnosed with androgenetic alopecia who meet at least one of the following diagnostic criteria: (1) Diagnosed based on the Basic and Specific (BASP) classification: - Basic type: Men or women diagnosed with androgenetic alopecia classified as M1 or higher, C1 or higher, or U1 or higher. - Specific type: Men or women diagnosed with androgenetic alopecia classified as V1 or higher, or F1 or higher. (2) Men diagnosed as stage 2 or 2A or higher based on the Norwood-Hamilton classification. (3) Women diagnosed as stage 1 or higher based on the Ludwig classification. 2. Participants who will not use any special hair products or perform hair treatments/manipulations during the study period. 3. Participants who will maintain the same hairstyle and color as at the time of the first visit throughout the study period. 4. Participants who voluntarily provided informed consent to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: The exclusion criteria for participants in the study were as follows: 1. Individuals with serious acute renal or cardiac diseases or other chronic conditions (such as hypertension or diabetes) that could affect the study results within the past 6 months. 2. Patients with blood glucose disorders or uncontrolled hypertension despite medication (fasting blood glucose = 126 mg/dL or postprandial blood glucose = 200 mg/dL, systolic blood pressure = 160 mmHg or diastolic blood pressure = 90 mmHg). 3. Individuals who are pregnant, breastfeeding, or planning to become pregnant within 6 months. 4. Individuals with psychiatric disorders. 5. Individuals with infectious skin diseases. 6. Individuals who have undergone surgical treatments for hair loss, such as hair transplantation or scalp reduction. 7. Individuals who have taken oral Dutasteride or Finasteride within the past 6 months. 8. Individuals who have applied topical hair growth products in the past month. 9. Individuals who have taken any of the following medications in the past month: steroids, cytotoxic agents, vasodilators, antihypertensives, anticonvulsants, beta-blockers, bronchodilators, diuretics, spironolactone, cimetidine, diazoxide, cyclosporine, ketoconazole. 10. Individuals who have applied topical steroid formulations to the scalp in the past month. 11. Individuals with severe seborrheic dermatitis, scalp psoriasis, scalp infections, or other conditions that could interfere with the application of the test substance. 12. Patients with alopecia areata, telogen effluvium, cicatricial alopecia, or other types of hair loss disorders, besides androgenetic alopecia. 13. Individuals with nutritional deficiencies due to excessive dietary restrictions or gastric surgery, or those taking nutritional supplements that could affect hair loss. 14. Individuals who have participated in another clinical trials within 4 weeks prior to this trial. 15. Any other individuals deemed unsuitable for the study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the total number of hairs observed through phototrichogram technology in areas of hair loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Researcher assessment through photography;Subject assessment of hair changes;Adverse effect;Vital signs (blood pressure, pulse, temperature);Scalp safety (subjective sensations of irritation by the study subjects and objective symptoms assessed through interviews and observations by the researcher) | — |
Countries
Korea, Republic of
Contacts
Public ContactBich-euro Park
Semyung University Oriental Medicine Hospital
Outcome results
None listed