A 24 week, Randomized, Double Blind, Placebo Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EVER Collagen on Hair health
- Conditions
- Not Applicable
- Registration Number
- KCT0008643
- Lead Sponsor
- ewtree
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Man and woman over the age of 19 and under the age of 60
2) Glossy scores according to the visual evaluation classification method correspond to 1 point or more and 3 points or less and a total hair damage score of less than 18 points evaluated according to exposure to risk factors
3) A person capable of maintaining the same hair shape and color during this human body application test
4) A person who agrees to participate in the human body application test and prepares a written consent form prior to the commencement of the human body application test
1) A person currently being treated for infectious diseases and malignant tumors, including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, psychosis, skin, etc
2) As of Visit 1, those who currently have dull dermatitis, scalp psoriasis, and scalp infection
3) A person who has other hair loss diseases, such as circular alopecia, resting alopecia, and scarlet alopecia, in addition to androgen alopecia
4) A person who plans to manage and operate hair supplies, hair products during this human body application test
5) A person who has received surgical treatment, such as hair transplantation and scalp reduction, within one year as of Visit 1
6) A person who has applied topical hair growth agents, wool, and hair growth agents for the last 1 month (30 days) or more as of Visit 1
7) A person who has applied topical steroids to the scalp for the last 1 month (30 days) or more as of Visit 1
8) Those who have been administered systemic steroids, cell death agents, vasodilators, antihypertensive agents, antiepileptic agents, beta receptor blockers, bronchodilators, diuretics, Cimetidine, Diazoxide, Cyclosporine, and Ketoconazole for the last 1 month or more (30 days)
9) A person who has taken oral Dutasteride or Finasteride within 6 months of visit 1
10) Patients with uncontrolled hypertension (as measured after stabilizing for 10 minutes with systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more)
11) Uncontrolled diabetics (above 180 mg/dL of fasting blood sugar)
12) Those with 2.4 mg/dL or more of creatine
13) Those with an AST (GOT) or ALT (GPT) of 120 IU/L or more
14) Those with a TSH of 0.1 µIU/mL or 10 µIU/mL or more
15) A person who has a problem with food intake for human body application tests due to severe gastrointestinal disorders
16) A person who has participated in other interventional clinical trials (including human application tests) within one month (30 days) of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
17) A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
18) A person who is sensitive to or allergic to food ingredients for this human body application test;
19) A person who is deemed inappropriate by the tester for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hair density, diameter;newborn hair gloss;IGA;Human satisfaction survey;Newborn hair tensile strength;newborn hair volume
- Secondary Outcome Measures
Name Time Method scalp moisture;scalp percutaneous moisture loss