Back to resultsOmegia Softgel Clinical Research Program
Primary Purpose
Skin Manifestations, Antioxidative Stress, Eye Strain
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Omegia® Softgel -B
Omegia® Softgel -A
Sponsored by
About this trial
This is an interventional supportive care trial for Skin Manifestations
Eligibility Criteria
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
Sites / Locations
- Chia Nan University of Pharmacy ＆ Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Omegia® Softgel -A
Omegia® Softgel -B
Arm Description
Take Omegia® Softgel -A once a day for 12 weeks
Take Omegia® Softgel-B once a day for 12 weeks
Outcomes
Primary Outcome Measures
Skin brightness
Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness. Units: arbitrary units
Skin redness
Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin redness. Units: arbitrary units
Skin moisture
Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units
Skin elasticity
Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units
Facial skin pores
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin pores. Units: arbitrary units
Facial skin texture
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units
Skin collagen content
Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units
Secondary Outcome Measures
Full Information
NCT ID
NCT05872178
First Posted
May 5, 2023
Last Updated
May 22, 2023
Sponsor
Chia Nan University of Pharmacy ＆ Science
1. Study Identification
Unique Protocol Identification Number
NCT05872178
Brief Title
Omegia Softgel Clinical Research Program
Official Title
Chia Nan University of Pharmacy & Science
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Nan University of Pharmacy ＆ Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Manifestations, Antioxidative Stress, Eye Strain, Vaginal Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omegia® Softgel -A
Arm Type
Placebo Comparator
Arm Description
Take Omegia® Softgel -A once a day for 12 weeks
Arm Title
Omegia® Softgel -B
Arm Type
Experimental
Arm Description
Take Omegia® Softgel-B once a day for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Omegia® Softgel -B
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Omegia® Softgel -A
Intervention Description
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 Outcome Measure Information:
Title
Skin brightness
Description
Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
Title
Skin redness
Description
Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin redness. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
Title
Skin moisture
Description
Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
Title
Skin elasticity
Description
Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
Title
Facial skin pores
Description
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin pores. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
Title
Facial skin texture
Description
VISIA Micro-Analysis Skin Image Analyzer was utilized to measure skin texture. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
Title
Skin collagen content
Description
Subcutaneous collagen scanner (DermaLab® Series SkinLab Combo) was utilized to measure skin collagen. Units: arbitrary units
Time Frame
Subjects will be tested in the 4th week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Chia Nan University of Pharmacy ＆ Science
City
Tainan
ZIP/Postal Code
71710
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17373178
Citation
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.
Results Reference
background
PubMed Identifier
26393899
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.
Results Reference
background
Learn more about this trial
Omegia Softgel Clinical Research Program
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