Skin ManifestationsNCT05872178
Omegia Softgel Clinical Research Program
A study testing Omegia® Softgel -B and Omegia® Softgel -A in people with Skin Manifestations and Antioxidative Stress, run by Chia Nan University of Pharmacy ＆ Science at 1 site in Taiwan.
Trial summary
Evaluate the improvement of regulation of skin and blood index composition after consumption of Omegia® Softgel Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Manifestations, Antioxidative Stress, Eye Strain
- What is being tested?
- Omegia® Softgel -B and Omegia® Softgel -A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ● Female subjects older than 45 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chia Nan University of Pharmacy & Science
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
- Skin Manifestations, Antioxidative Stress, Eye Strain, Vaginal Disease
- Being tested
- Omegia® Softgel -B, Omegia® Softgel -A
- Medical subject headings
- Skin Manifestations, Asthenopia, Vaginal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omegia® Softgel -BDietary 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 -ADietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Omegia® Softgel -A | Placebo comparator | Take Omegia® Softgel -A once a day for 12 weeks Receives: Dietary Supplement: Omegia® Softgel -A |
| Omegia® Softgel -B | Experimental | Take Omegia® Softgel-B once a day for 12 weeks Receives: Dietary Supplement: Omegia® Softgel -B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin brightness
Skin color difference analyzer (Chroma Meter MM500) was utilized to measure skin brightness. Units: arbitrary units
Measured: 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
Measured: Subjects will be tested in the 4th week
Skin moisture
Skin moisture meter (Corneometer CM825) was utilized to measure skin moisture. Units: arbitrary units
Measured: Subjects will be tested in the 4th week
Skin elasticity
Skin elastometer (Soft Plus) was utilized to measure skin elasticity. Units: arbitrary units
Measured: 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
Measured: 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
Measured: 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
Measured: Subjects will be tested in the 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start15 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skin ManifestationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Nan University of Pharmacy ＆ Science
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872178
- Sponsor's protocol ID
- TSMHIRB-2-029-2.2
- Status last verified
- May 2023
- First submitted
- 5 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 17373178Rodrigues 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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chia Nan University of Pharmacy & Science
- ClinicalTrials.gov ID
- NCT05872178
- Acronym / sponsor ID
- TSMHIRB-2-029-2.2
- Conditions
- Skin Manifestations, Antioxidative Stress, Eye Strain, Vaginal Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chia Nan University of Pharmacy ＆ ScienceUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omegia® Softgel -A | Placebo comparator | Dietary Supplement: Omegia® Softgel -ATake Omegia® Softgel -A once a day for 12 weeks |
| Omegia® Softgel -B | Experimental | Dietary Supplement: Omegia® Softgel -BTake Omegia® Softgel-B once a day for 12 weeks |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ● Female subjects older than 45 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omegia® Softgel -BHow 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 supplement | Omegia® Softgel -B |
| Omegia® Softgel -AHow 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 supplement | Omegia® Softgel -A |
Primary outcome
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Background: PubMed 17373178Gold 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.
- Background: PubMed 26393899Rodrigues 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omegia® Softgel -B and Omegia® Softgel -A in people with Skin Manifestations and Antioxidative Stress, run by Chia Nan University of Pharmacy ＆ Science at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin brightness (time frame: Subjects will be tested in the 4th week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05872178, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.