Omegia Softgel Clinical Research Program

Skin Manifestations Clinical Trial

Official title:

Chia Nan University of Pharmacy & Science

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05872178
• Other study ID #: TSMHIRB-2-029-2.2
• Status: Completed
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Chia Nan University of Pharmacy & Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenopia
• Eye Strain
• Skin Manifestations
• Vaginal Disease
• Vaginal Diseases

Intervention

Dietary Supplement:
• Omegia® Softgel -B
How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.
• Omegia® Softgel -A
How to use: Take once a day for 12 weeks Subject precautions: If the health products and cosmetic care products used contain sea buckthorn ingredients, stop using them.

Locations

Country	Name	City	State
Taiwan	Chia Nan University of Pharmacy & Science	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Nan University of Pharmacy & Science

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Gold MH, Goldman MP, Biron J. Efficacy of novel skin cream containing mixture of human growth factors and cytokines for skin rejuvenation. J Drugs Dermatol. 2007 Feb;6(2):197-201. — View Citation

Rodrigues F, Sarmento B, Amaral MH, Oliveira MB. Exploring the antioxidant potentiality of two food by-products into a topical cream: stability, in vitro and in vivo evaluation. Drug Dev Ind Pharm. 2016;42(6):880-9. doi: 10.3109/03639045.2015.1088865. Epub 2015 Sep 22. — View Citation

Outcome

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