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Effects of FSH-SP-S for skin health

A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of FSH-SP-S for skin health

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007792
Enrollment
100
Registered
2022-10-12
Start date
2021-04-08
Completion date
Unknown
Last updated
2022-10-24

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

Conditions

None listed

Interventions

Dietary Supplement : FSH-SP-S or placebo Tablet, 1,000mg/tablet, 2 tablets/time/day, Oral administration for 12 weeks

Sponsors

FromBIO
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Women aged 30 to 60 2) A person with dry skin (skin moisture index of 49 or less) and who has begun to produce wrinkles around the eyes according to the visual evaluation 3) A person who voluntarily agrees to participate in the human body application test and signs informed consent form.

Exclusion criteria

Exclusion criteria: 1) A person with sensitive, hypersensitive, and eczema skin diseases (atopic dermatitis, suppurative acne, eczema, etc.) 2) A person who has skin abnormalities such as acne, erythema, spots, capillary dilatation, burn marks, scars, tattoos, etc. at the test site (measuring part) 3) A person who has continuously applied or consumed placental-containing cosmetics, medicines, and non-drugs for at least one month, within three months prior to participating in the study 4) A person who is taking health functional food, non-drugs, or other processed food for the purpose of moisturizing the skin and improving wrinkles 5) A person who has undergone dermatological procedures including skin dermis and Botox within 6 months before participating in the study 6) Pregnant women, lactating women and those with plans for pregnancy within the next six months 7) A person on oral contraceptives 8) A person who is allergic to cosmetics, medicines, non-drugs, or ultraviolet rays or sunlight 9) A person who is constantly exposed to excessive sunlight or ultraviolet rays or plan to do so (e.g., outdoor sports (swimming, skiing, hiking), driving, walking travel, tanning, etc.) 10) A person with hypertension and diabetes who are not controlled even though they are on medication 11) A person with renal dysfunction (increased more than 1.5 times the normal upper limit of creatine) and liver dysfunction (increased more than 2.5 times the normal upper limit of AST, ALT) 12) A person with chronic gastrointestinal disorders, autoimmune diseases, malignancy, mental illness and alcoholism 13) A person who is allergic to or overreacted to the ingredients of the test product 14) A person who has participated in another clinical trial or human application test one month before the start of the test 15) A person deemed inappropriate by the principal investigator to participate in the research

Design outcomes

Primary

MeasureTime frame
skin moisture content (Corneometer)

Secondary

MeasureTime frame
Visual evaluation of skin wrinkles;Skin wrinkle evaluation (Visiometer);Percutaneous moisture loss (Tewameter);Skin pH;Skin health improvement survey assessment

Countries

Korea, Republic of

Contacts

Public ContactMiji Lee

Research Institute of Medical Nutrition

mj_ntneo@naver.com+82-2-969-7715

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026