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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05872178
Other study ID # TSMHIRB-2-029-2.2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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