Omegia Softgel Clinical Research Program

Not Applicable

Completed

• Conditions: Skin Manifestations; Antioxidative Stress; Eye Strain; Vaginal Disease
• Interventions: Dietary Supplement: Omegia® Softgel -A; Dietary Supplement: Omegia® Softgel -B

• Registration Number: NCT05872178
• Lead Sponsor: Chia Nan University of Pharmacy ＆ Science

Brief Summary

Evaluate the improvement of regulation of skin and blood index composition after consumption of Omegia® Softgel

Detailed Description

The blood biochemical analysis at Weeks 0 and 12, including Catalase, Tumor necrosis factor-α, Cholesterol, Triglyceride, High-density lipoprotein-Cholesterol and Low-density lipoprotein- Cholesterol.

The Skin assessment at Weeks 0, 4 and 12, including Skin brightness, Skin redness sensitivity index, Skin moisture, Skin elasticity, Facial skin pores, Facial skin texture and Skin collagen content.

Study Timeline

• Study Start: 2021-04-15
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-05-24
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

● Female subjects older than 45 years

Exclusion Criteria

• Involuntary subjects
• Skin disease, liver cirrhosis or chronic renal failure
• Those with known cosmetic, drug or food allergies
• Pregnant women and nursing mothers.
• Those taking chronic disease medication
• The subject has received laser facial treatment, fruit acid facial peeling, long-term sunlight, etc. within four weeks of the test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omegia® Softgel -A	Omegia® Softgel -A	Take Omegia® Softgel -A once a day for 12 weeks
Omegia® Softgel -B	Omegia® Softgel -B	Take Omegia® Softgel-B once a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Facial skin texture	Subjects will be tested in the 4th week	VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units
Skin brightness	Subjects will be tested in the 4th week	Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness. Units: arbitrary units
Skin redness	Subjects will be tested in the 4th week	Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin redness. Units: arbitrary units
Skin moisture	Subjects will be tested in the 4th week	Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units
Facial skin pores	Subjects will be tested in the 4th week	VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin pores. Units: arbitrary units
Skin collagen content	Subjects will be tested in the 4th week	Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units
Skin elasticity	Subjects will be tested in the 4th week	Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units

Trial Locations

Locations (1)

Chia Nan University of Pharmacy ＆ Science; 🇨🇳 Tainan, Taiwan