Efficacy Testing of VeCollal Products

• Sponsor: TCI Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05789368
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 6.8
• Patients Per Site Per Month: 13.3

Study Details

Study Description

Brief Summary

To assess VeCollal formula on skin condition improvement

Condition or Disease	Intervention/Treatment	Phase
Skin Condition	Dietary Supplement: Placebo sachet; Dietary Supplement: VeCollal sachet; Dietary Supplement: Collagen sachet	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Efficacy Testing of VeCollal Products
• Actual Study Start Date: Feb 6, 2023
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo sachet consume 1 sachet per day	Dietary Supplement: Placebo sachet; consume 1 sachet per day
Experimental: VeCollal sachet consume 1 sachet per day	Dietary Supplement: VeCollal sachet; consume 1 sachet per day
Active Comparator: Collagen sachet consume 1 sachet per day	Dietary Supplement: Collagen sachet; consume 1 sachet per day

Outcome Measures

Primary Outcome Measures

1. The change of skin collagen density [Change from Baseline skin collagen density at 8 weeks]

   DermaLab® Series SkinLab Combo was utilized to measure skin pores. Units: arbitrary units

2. The change of skin wrinkles [Change from Baseline skin wrinkles at 8 weeks]

   VISIA Complexion Analysis System was utilized to measure skin wrinkles. Units: arbitrary units

3. The change of skin texture [Change from Baseline skin texture at 8 weeks]

   VISIA Complexion Analysis System was utilized to measure skin texture. Units: arbitrary units

4. The change of skin elasticity [Change from Baseline skin elasticity at 8 weeks]

   SoftPlus was utilized to measure skin elasticity. Units: arbitrary units

Secondary Outcome Measures

1. The change of skin melanin index [Change from Baseline skin melanin index at 8 weeks]

   Mexameter® MX18 was utilized to measure skin melanin index. Units: arbitrary units

2. The change of skin L* value [Change from Baseline skin L* value at 8 weeks]

   Chroma Meter MM500 was utilized to measure skin L* value. Units: arbitrary units, 0-100

3. The change of skin erythema index [Change from Baseline skin erythema index at 8 weeks]

   Mexameter® MX18 was utilized to measure skin erythema index. Units: arbitrary units

4. The change of skin moisture [Change from Baseline skin moisture index at 8 weeks]

   Corneometer® CM825 was utilized to measure skin moisture. Units: arbitrary Corneometer® units 0-120

5. The change of transepidermal water loss (TEWL) [Change from Baseline skin TEWL at 8 weeks]

   Tewameter® TM 300 was utilized to measure TEWL. Units: g/hm²

6. The change of skin pores [Change from Baseline skin pores at 8 weeks]

   VISIA Complexion Analysis System was utilized to measure skin pores. Units: arbitrary units

Other Outcome Measures

1. The change of liver function biomarkers (AST, ALT) of blood [Change from Baseline liver function biomarkers at 8 weeks]

   Fasting venous blood was sampled to measure liver function biomarkers

2. The change of renal function biomarkers (creatinine, BUN) of blood [Change from Baseline renal function biomarkers at 8 weeks]

   Fasting venous blood was sampled to measure renal function biomarkers

3. The change of fasting blood glucose [Change from Baseline blood glucose at 8 weeks]

   Fasting venous blood was sampled to measure blood glucose

4. The change of blood lipid profiles (total cholesterol, triglyceride) [Change from Baseline blood lipid profiles at 8 weeks]

   Fasting venous blood was sampled to measure blood lipid profiles

5. The change of self-assessment skin condition [Change from Baseline skin condition at 8 weeks]

   A self-assessment questionnaire was collected to evaluate skin condition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 (> 3 hr/week) in the past 4 weeks.

• Constant drug use

• Students who are currently taking courses taught by the principal investigator of this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chia Nan University of Pharmacy ＆ Science	Tainan		Taiwan	71710

Sponsors and Collaborators

• TCI Co., Ltd.

Investigators

• Principal Investigator: Chia-Hua Liang, Chia Nan University of Pharmacy ＆ Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TCI Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05789368
• Other Study ID Numbers: 22-112-A
• First Posted: Mar 29, 2023
• Last Update Posted: Mar 29, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Diseases

Study Results

No Results Posted as of Mar 29, 2023