Clinical trial NCT04878536: Efficacy Testing of Collagen Elixir
Official title: Efficacy Testing of Collagen Drink
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess Isagenix-Collagen Elixir on skin condition improvement


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
* Constant drug use
* Participated cosmetic product human study in the past 3 months.

Primary outcomes:
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 4 weeks
measure: The change of skin texture
timeFrame: Change from Baseline skin texture at 4 weeks
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 4 weeks
measure: The change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 4 weeks
measure: The change of MMP-1 of blood
timeFrame: Change from Baseline MMP-1 at 4 weeks
measure: The change of TIMP-1 of blood
timeFrame: Change from Baseline TIMP-1 at 4 weeks
Secondary outcomes:
measure: The change of skin melanin index
timeFrame: Change from Baseline skin melanin index at 4 weeks
measure: The change of skin L* value
timeFrame: Change from Baseline L* value at 4 weeks
measure: The change of skin moisture
timeFrame: Change from Baseline skin moisture at 4 weeks
measure: The change of skin spots
timeFrame: Change from Baseline skin spots at 4 weeks
measure: The change of skin UV spots
timeFrame: Change from Baseline skin UV spots at 4 weeks
measure: The change of skin brown spots
timeFrame: Change from Baseline skin brown spots at 4 weeks
measure: The change of TNF-α of blood
timeFrame: Change from Baseline TNF-α at 4 weeks
measure: The change of IL-10 of blood
timeFrame: Change from Baseline IL-10 at 4 weeks
measure: The change of SOD-RBC of blood
timeFrame: Change from Baseline SOD-RBC at 4 weeks
measure: The change of f-thiols of blood
timeFrame: Change from Baseline f-thiols at 4 weeks
measure: The change of t-GSH of blood
timeFrame: Change from Baseline t-GSH at 4 weeks
measure: The change of GST-RBC of blood
timeFrame: Change from Baseline GST-RBC at 4 weeks
measure: The change of MDA of blood
timeFrame: Change from Baseline MDA at 4 weeks
measure: The change of blood total antioxidant capacity (TAC)
timeFrame: Change from Baseline TAC at 4 weeks
Other outcomes:
measure: The change of total cholesterol of blood
timeFrame: Change from Baseline total cholesterol at 4 weeks
measure: The change of triglyceride of blood
timeFrame: Change from Baseline triglyceride at 4 weeks
measure: The change of SGOT of blood
timeFrame: Change from Baseline SGOT at 4 weeks
measure: The change of SGPT of blood
timeFrame: Change from Baseline SGPT at 4 weeks
measure: The change of BUN of blood
timeFrame: Change from Baseline BUN at 4 weeks
measure: The change of creatinine of blood
timeFrame: Change from Baseline creatinine at 4 weeks
measure: The change of uric acid of blood
timeFrame: Change from Baseline uric acid at 4 weeks
Locations:
city: Tainan City
country: Taiwan
facility: Chia Nan University of Pharmacy & Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang
role: PRINCIPAL_INVESTIGATOR
References: