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Completed

NCT Number: NCT05872178

Omegia Softgel Clinical Research Program

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

Completed

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Key information

Conditions

Skin Manifestations Antioxidative Stress Asthenopia Eye Diseases Eye Strain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Vaginal Disease Vaginal Diseases

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chia Nan University of Pharmacy ＆ Science

Tainan, 71710, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omegia® Softgel -B

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Skin brightness

    Time frame: Subjects will be tested in the 4th week

    Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness. Units: arbitrary units

  2. Skin redness

    Time frame: Subjects will be tested in the 4th week

    Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin redness. Units: arbitrary units

  3. Skin moisture

    Time frame: Subjects will be tested in the 4th week

    Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units

  4. Skin elasticity

    Time frame: Subjects will be tested in the 4th week

    Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units

  5. Facial skin pores

    Time frame: Subjects will be tested in the 4th week

    VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin pores. Units: arbitrary units

  6. Facial skin texture

    Time frame: Subjects will be tested in the 4th week

    VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units

  7. Skin collagen content

    Time frame: Subjects will be tested in the 4th week

    Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units

Sponsors and collaborators

Lead sponsor

Chia Nan University of Pharmacy ＆ Science

Other

Registry information

Official study title

Chia Nan University of Pharmacy & Science

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 24, 2023
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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