NCT05872178

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

May 5, 2023

Last Update Submit

May 22, 2023

Conditions

Skin ManifestationsAntioxidative StressEye StrainVaginal Disease

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • Skin moisture

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

    Subjects will be tested in the 4th week

  • Skin elasticity

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

    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

    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

    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

    Subjects will be tested in the 4th week

Study Arms (2)

Omegia® Softgel -A

PLACEBO COMPARATOR

Take Omegia® Softgel -A once a day for 12 weeks

Dietary Supplement: Omegia® Softgel -A

Omegia® Softgel -B

EXPERIMENTAL

Take Omegia® Softgel-B once a day for 12 weeks

Dietary Supplement: Omegia® Softgel -B

Interventions

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 -B
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.

Omegia® Softgel -A

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ● Female subjects older than 45 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chia Nan University of Pharmacy ＆ Science

Tainan, 71710, Taiwan

Location

Related 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.

    PMID: 17373178BACKGROUND

  • 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.

    PMID: 26393899BACKGROUND

MeSH Terms

Conditions

Skin ManifestationsAsthenopiaVaginal Diseases

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsEye DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2023

First Posted

May 24, 2023

Study Start

April 15, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)