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A pharmacokinetic study of active ingredient in hair restorer.

A pharmacokinetic study of active ingredient in hair restorer. - A pharmacokinetic study of active ingredient in hair restorer.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023689
Enrollment
14
Registered
2016-08-20
Start date
2016-08-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alopecia prematura

Interventions

Administration of commercial hair restorer on scalp twice at an interval of 2 weeks.

Sponsors

SOUKEN CO.,LTD
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Mail patients with alopecia premature (typeVI or early- or mid-stage of typeII and typeIV in Ogata's classification) 2) Patients with 60-75kg body weight. 3) Non-smoker 4) Patients with negative in viral test, 5) Patients without problem in health especially in metabolic function.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1)Photographs of occipital and parietal region scalp. 2)Results of blood chemical analysis and skin surface topography before administration.

Countries

Japan

Contacts

Public ContactReiko Maruya

SOUKEN CO.,LTD Secretariat

r_maruya@mail.souken-r.com03-5733-1555

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026