CompletedNCT05872178Updated May 24, 2023

Omegia Softgel Clinical Research Program

An interventional study of Omegia® Softgel -B and Omegia® Softgel -A in Skin Manifestations, Antioxidative Stress and Eye Strain, sponsored by Chia Nan University of Pharmacy ＆ Science. Completed at 1 site in Taiwan. Open to female participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-24.

Sponsored by Chia Nan University of Pharmacy ＆ Science · Not applicable, Interventional, and Supportive care

From the registry’s dates

Registered 2 years after the study started (first participant enrolled Apr 2021, registered May 2023).

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 45 Years to 75 Years
Sex: Female

Study summary

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

Read the 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.

Conditions studied

Skin Manifestations
Antioxidative Stress
Eye Strain
Vaginal Disease

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In context

Skin Manifestations

29 studies on the registry are indexed under Skin Manifestations; 5 are open to participants now.

This study's enrollment of 40 is below the median of 75 across 23 interventional studies indexed under Skin Manifestations.

Browse Skin Manifestations studies →

Lead sponsor

Chia Nan University of Pharmacy ＆ Science is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 75 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

● Female subjects older than 45 years

Exclusion criteria

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

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 40 participants (actual)

Study arms

Placebo comparator
Omegia® Softgel -A
Take Omegia® Softgel -A once a day for 12 weeks
Dietary Supplement: Omegia® Softgel -A
Experimental
Omegia® Softgel -B
Take Omegia® Softgel-B once a day for 12 weeks
Dietary Supplement: Omegia® Softgel -B

Interventions

Dietary supplementOmegia® 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.
Dietary supplementOmegia® 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.

What researchers measure

Primary outcomes

Skin brightness
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
Skin redness
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
Skin moisture
Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units
Time frame: Subjects will be tested in the 4th week
Skin elasticity
Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units
Time frame: Subjects will be tested in the 4th week
Facial skin pores
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
Facial skin texture
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
Skin collagen content
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

Study locations

1 site

Chia Nan University of Pharmacy ＆ Science
Tainan, 71710, Taiwan

References and documents

Publications

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. PubMed 17373178 ↗
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. PubMed 26393899 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Dec 2022, 20 months.

Of 14 interventional studies with no phase under Skin Manifestations, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 17. This study's 20 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered: May 5, 2023
First posted: May 24, 2023
StartActual: Apr 15, 2021
Primary completionActual: Dec 31, 2022
CompletionActual: Dec 31, 2022
Last update: May 24, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05872178
Lead sponsor: Chia Nan University of Pharmacy ＆ Science
Responsible party: Sponsor
First posted: May 24, 2023
Start date: Apr 15, 2021
Primary completion: Dec 31, 2022
Completion: Dec 31, 2022
Last update: May 24, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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