Sleep Disturbance Clinical Trial
Official title:
Efficacy Testing of Collagen Drink on Skin Beauty and Sleep Aid
| Verified date | March 2022 |
| Source | TCI Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess Collagen Drink on skin condition and sleep quality improvement
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | April 30, 2022 |
| Est. primary completion date | February 28, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 - Constant drug use - Received facial laser therapy, chemical peeling or UV overexposure (>3 hours everyday) in the past 4 weeks. - Students taught by the PI |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Chia Nan University of Pharmacy & Science | Tainan |
| Lead Sponsor | Collaborator |
|---|---|
| TCI Co., Ltd. |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The change of skin wrinkles | VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units | Change from Baseline skin wrinkles at 8 weeks | |
| Primary | The change of skin texture | VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units | Change from Baseline skin texture at 8 weeks | |
| Primary | The change of skin collagen density | DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units | Change from Baseline skin collagen density at 8 weeks | |
| Primary | The change of skin elasticity | Cutometer® MPA580 was utilized to measure skin elasticity. Units: arbitrary units | Change from Baseline skin elasticity at 8 weeks | |
| Primary | The change of skin L* value | Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100 | Change from Baseline L* value at 8 weeks | |
| Primary | The change of sleep quality | Self-assessment questionnaire was utilized to survey sleep quality. | Change from Baseline sleep quality at 8 weeks | |
| Primary | The change of AGEs of blood | Venous blood was sampled to measure AGEs | Change from Baseline AGEs at 8 weeks | |
| Primary | The change of TIMP-1 of blood | Venous blood was sampled to measure TIMP-1 | Change from Baseline TIMP-1 at 8 weeks | |
| Primary | The change of desmosine of blood | Venous blood was sampled to measure desmosine | Change from Baseline desmosine at 8 weeks | |
| Secondary | The change of skin melanin index | Soft Plus was utilized to measure skin melanin index. Units: arbitrary units | Change from Baseline skin melanin index at 8 weeks | |
| Secondary | The change of skin pores | VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units | Change from Baseline skin pores at 8 weeks | |
| Secondary | The change of skin a* value | Chroma Meter MM500 was utilized to measure skin a* value. Units: arbitrary units | Change from Baseline skin a* value at 8 weeks | |
| Secondary | The change of skin hydration | Corneometer® CM825 was utilized to measure skin hydration. Units: arbitrary Corneometer® units 0-120 | Change from Baseline skin hydration at 8 weeks | |
| Secondary | The change of transepidermal water loss | Tewameter® TM300 was utilized to measure skin hydration. Units: g/hm² | Change from Baseline transepidermal water loss at 8 weeks |
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