A pharmacokinetic study of active ingredient in hair restorer.
- Conditions
- alopecia prematura
- Registration Number
- JPRN-UMIN000023689
- Lead Sponsor
- SOUKEN CO.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 14
Not provided
1) Patients taking or using medicine which can have influence on the result. 2) Patients having daily health food which can have influence on the result. 3) Patients who is capable to have allergic responses to constituent parts of test articles. 4) Patients participating in other clinical tests. 5) Patients with any histories of hepatic disorder,nephropathy,heart disease,dysuria. 6) Patients with alopecia other than alopecia premature or unexplained alopecia. 7) Patients with rapid hair loss or patchy alopecia 8) Patients with wound or eczema or inflammation on scalp 9) Patients with allergic responses to any drug or cosmetic. 10) Patients treated for hypotension or hypertension. 11) Patients with systolic pressure under 100mmHg or above 160mmHg. 12) Patients with diastolic pressure above 110mmHg. 13) Patients with swelling. 14) Patients with thyroid dysfunction. 15) Patients with arrhythmia and severe anemia. 16) Patients using anticoagulant. 17) Patients with subjective symptoms of anemia. 18) Patients whose blood was collected over 400mL during 3 months or over 200mL during 2 months. 19) Patients treated hair addition or hair transplantation. 20) Patients haven one's hair permed in 1 month. 21) Patients with histories of positives in virus test. 22) Patients met any of following criterias. -Total cholesterol:280mg/dL or more -Triglyceride:400 mg/dL or more -FBG:130 mg/dL or more -Uric acid:9.0 mg/dL or more -Creatinine:1.5 mg/dL or more 23) Patients with 2.5 times more than standard value of either g-GT,AST,ALT,direct bilirubin or total bilirubin. 24) Patients deemed inappropriate to participate in this study by the principal investigator or sub-investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameter of active ingredient in hair restorer calculated from the concentration of blood concentration before administration and 1,2,4,6,8,12,24,48hrs after, and urinary concentration before administration and 2,4,6,8,12,24hrs after.
- Secondary Outcome Measures
Name Time Method 1)Photographs of occipital and parietal region scalp. 2)Results of blood chemical analysis and skin surface topography before administration.