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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06306105
Other study ID # 23-118-B
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2024
Est. completion date December 1, 2024

Study information

Verified date March 2024
Source TCI Co., Ltd.
Contact Chia-Hua Liang, Ph.D.
Phone +886-06-2664911
Email tinna_ling@mail.cnu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To assess the anti-aging efficacy of Marine Collagen Peptides on skin, hair and finger nails for human


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthy adults aged above 18 years old Exclusion Criteria: - Subjects who are not volunteers - Subjects who have been diagnosed with dermatitis, cirrhosis, and chronic kidney failure - Subjects who have known cosmetic, drug or food allergies. - Patients are taking medicine for chronic diseases - Subjects receiving treaments for scalp, hair transplant, and other scalp medical care in past 12 weeks. - Subjects getting a manicure and perm in past 12 weeks. - Female who is pregnant or nursing or planning to become pregnant during the course of the study. - Subjects receiving facial laser therapy, chemical peeling or UV overexposure (> 3 hr/week) in the past 12 weeks. - Students who are currently taking courses taught by the principal investigator of this trial. - Subjects are not willing to reveal the results of pictures after taking the product - Vegetarian.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Marine Collagen Peptides
consume 1 bottle per day
placebo drink
consume 1 bottle per day

Locations

Country Name City State
Taiwan Chia Nan University of Pharmacy & Science Pingtung

Sponsors (1)

Lead Sponsor Collaborator
TCI Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change of skin hydation Corneometer® CM825 (CK, Germany) was utilized to measure skin surface hydation. Units: arbitrary Corneometer® units 0-120. Change from Baseline skin skin hydation at 12 weeks
Primary The change of skin wrinkles VISIA Complexion Analysis was utilized to measure skin wrinkles. Units: the amount of detectable wrinkles Change from Baseline skin wrinkles at 12 weeks
Primary The change of skin elasticity Cutometer® MPA580 was utilized to measure skin elasticity. Units: visco-elasticity in %. Change from Baseline skin elasticity at 12 weeks
Primary The change of skin collagen density DermaLab® Series SkinLab Combo was utilized to measure skin collagen density. Units: arbitrary units Change from Baseline skin collagen density at 12 weeks
Primary The change of hair diameters Mitutoyo C/N293-100 was utilized to measure hair diameters. Units: millimeter Change from Baseline hair diameters at 12 weeks
Primary The change of hair loss amount Collect and measure the weight of loss hair. Units: gram Change from Baseline hair loss amount at 12 weeks
Primary The change of hair roots diameters Mitutoyo C/N293-100 was utilized to measure hair roots diameters. Units: millimeter Change from Baseline hair roots diameters at 12 weeks
Primary The change of hair density Soft Plus was utilized to picture and observe hair density. Change from Baseline hair density at 12 weeks
Primary The change of hair follicle strength Pull up the hair of the frontal bone, temporal bone and occipital bone (approximately 60 hairs/area) to assess the number of hair loss in each area. Units: the number of loss hair Change from Baseline hair follicle strength at 12 weeks
Primary The change of thumbs nail color Chroma Meter MM500 was utilized to measure thumbs nail color. Units: L* index Change from Baseline thumbs nail color at 12 weeks
Primary The change of nails appearence Picture taken was utilized to record and observe nails appearence. Change from Baseline nails appearence at 12 weeks
Primary The change of nails growth Marking the position of middle fingers lunula was utilized to record and observe nails growth. Units: milimeter Change from Baseline marking position at 12 weeks
Primary The degree of nails fragility Iron ruler was utilized to evaluate nails fragility. Picture taken was utilized to record and observe the change of nails fragility. Change from Baseline nails fragility at 12 weeks
Secondary The change of self-assessment skin, hair, and nails condition A self-assessment questionnaire was collected and evaluate skin, hair, and nails condition Change from Baseline skin, hair, and nails condition at 12 weeks
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