None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male and female adults aged 19 to 60 years. 2. Subjects with mild to moderate hair damage (hair gloss score 1–3 and total hair damage score <18). 3. Subjects willing to refrain from chemical hair treatments (perm, dyeing, bleaching, hair clinic treatments, etc.) during the study. 4. Subjects who agree to maintain the same hairstyle throughout the study. 5. Subjects who voluntarily signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of malignancy within the past 5 years. 2. Psychiatric disorders. 3. Infectious scalp diseases. 4. Hair loss disorders. 5. Clinically significant gastrointestinal, hepatobiliary, endocrine, hematologic, or gynecologic diseases. 6. History of hypersensitivity to the investigational product or tattoo ink used for hair assessment. 7. Abnormal laboratory findings or uncontrolled hypertension/diabetes meeting protocol-defined exclusion criteria. 8. Use of prohibited medications specified in the protocol. 9. Pregnant or breastfeeding women or women planning pregnancy. 10. Excessive alcohol consumption or smoking. 11. Participation in another clinical trial within the previous 3 months. 12. Subjects considered unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in hair diameter measured by phototrichogram;Change in hair gloss score assessed by scanning electron microscopy (SEM);Mean subject satisfaction score for hair improvement | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in hair diameter;Change in hair gloss score assessed by SEM;Subject satisfaction questionnaire score;Change in hair gloss measured using a Glossymeter;Change in hair count;Change in scalp moisture content;Change in transepidermal water loss (TEWL);Change in hair tensile strength;Change in new hair root volume angle;Subject global assessment score;Investigator global assessment;Investigator assessment of hair gloss improvement;Adverse events;Vital signs;Physical examination;Laboratory tests | — |
Countries
Korea, Republic of
Contacts
Global Medical Research Center