Clinical trial for Comparative Study on the effect of oral intake of LB-P9 on maintaining hair health(Random Allocation, Double Blindness, Control Comparison)
- Conditions
- Diseases of the skin and subcutaneous tissue
- Registration Number
- KCT0009499
- Lead Sponsor
- ISCure Biosciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
1) Men and women aged 18 to 60 with mild or more damaged hair without healthy hair loss disease
- Adult men and women with a gloss score of 1 to 3 according to the visual evaluation classification method, and a total score of hair damage assessed according to exposure to risk factors, less than 18.
2) Subjects who will not engage in any special hair products or hair care and manipulation during the study period
3) Those who have agreed to maintain the same hair shape, color and length during the study period
- Those whose hair length is 8cm or more when measured from the top of the head
4) A person who voluntarily agrees to participate and signs a written consent form before the start of this human body application test
1) Severe acute kidney or heart disease that could affect the results of the trial in the last six months
2) Patients with hypertension who are not controlled during screening (blood pressure 180/110mmHg or higher; however, those who are stably controlling blood pressure with drug treatment can participate)
3) Diabetes patients who are not controlled during screening (HbA1c 9% or more)
4) Patients with uncontrolled hyperthyroidism or hypothyroidism at screening time
5) In clinical laboratory examination results during screening, creatinine concentration is more than twice the upper limit of the research institute, or patients with chronic renal failure or kidney disease requiring dialysis
6) At screening, clinical laboratory examination results show that AST or ALT concentrations are more than twice the normal upper limit of the research institute, or drug/alcoholic hepatitis, cirrhosis, fatty liver patients requiring treatment
7) a person who complains of severe gastrointestinal symptoms
8) A person with a history of malignant tumors within the past 5 years
9) a person with a psychiatric condition
10) A person with an infectious skin disease
11) Patients with other hair loss diseases such as androgenic alopecia, atypical alopecia, resting alopecia, and scarring alopecia
12) A person who is pregnant, lactating, or planning to become pregnant
13) Those who have taken oral Dutasteride or Finasteride in the last 6 months
14) Those who have been applying local hair growth agents, wool, and hair growth agents for the past month
15) Those who have taken the following drugs in the last 1 month: Steroids, apoptosis, vasodilators, antihypertension, anti-interstitial drugs, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, Ketoconazole
16) Those who have been applying topical steroids to their scalp for the past month
17) Those who have been taking lactobacilli preparations within the last month
18) A person who has taken drugs that may affect hair growth within three months or is currently taking them
19) A person who has consumed functional health food recognized by the Ministry of Food and Drug Safety within three months prior to the start of the test
20) A person who participated in other human application tests and clinical trials within three months prior to the start of this human application test
21) A person whose alcohol intake falls under the following (men's 40g/day or more, women's 20g/day or more, alcohol 40g=17 degree soju 0.8 bottles or 1L of beer)
22) Those who are allergic or have side effects to test foods
23) A person who is deemed unsuitable for the examination by the examiner for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method