NCT02373111

Brief Summary

Photoaging is caused by the superposition of chronic ultraviolet (UV)-induced damage on the intrinsic aging process, and accounts for the majority of age-associated changes in skin appearance. Reactive oxygen species (ROS) play a key role in UV-induced skin damage and diminish skin matrix protein levels, leading skin aging. Strategies utilizing endogenous skin antioxidants as well as plant-derived or synthetic compounds have been examined. Astaxanthin mainly from marine algae and crustaceans is a kind of carotenoids which were well-known photo-protective agents with strong antioxidant activity. Several studies have revealed that supplementation of astaxanthin effectively protect skin against UV damage through free radicals. In addition, matrix metalloproteinase-1 induced by UV irradiation is an important step toward skin aging. Recently, many studies pointed out that phytoestrogens exhibit agonistic and antagonistic estrogen activities, suppressing activity of MMP-1 in skin. Isoflavone is a kind of phytoestrogen from soybean and mainly act on skin and bones, inhibiting MMP-1 effectively. The present study is designed to take isoflavone combined with astaxanthin to maximize their anti-aging ability and objectively measure the effects of the mixture on facial wrinkles, hydration, and elasticity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 14, 2016

Status Verified

June 1, 2016

Enrollment Period

8 months

First QC Date

February 20, 2015

Last Update Submit

June 11, 2016

Conditions

AgeingPhoto-aging

Keywords

Anti-agingIsoflavonesAstaxanthineSkin aging

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in skin wrinkles

    Facial wrinkles in the crow's feet area measured by Skin Visiometer

    Twenty-four weeks

Secondary Outcomes (3)

  • Change from baseline in skin elasticity

    Twenty-four weeks

  • Change from baseline in epidermal hydration

    Twenty-four weeks

  • Change from baseline in skin barrier integrity

    Tewnty-four weeks

Study Arms (2)

Isoflavone and Astaxanthin

ACTIVE COMPARATOR

Each subject takes one active tablet per day for 24 weeks. Each tablet contains isoflavone 27mg and astaxanthin 4mg.

Dietary Supplement: IsoflavoneDietary Supplement: Astaxanthin

Placebo

PLACEBO COMPARATOR

Each subject takes one placebo tablet per day for 24 weeks.

Dietary Supplement: Placebo

Interventions

IsoflavoneDIETARY_SUPPLEMENT
Isoflavone and Astaxanthin
AstaxanthinDIETARY_SUPPLEMENT
Isoflavone and Astaxanthin
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy females aged ≥ 45 years
  • Facial wrinkle grade 2 to 4

You may not qualify if:

  • received medical or cosmetic treatment that interferes with the general aging process at least 3 months before the study
  • received any hormone replacement therapy at least 3 months before the study
  • reported taking functional foods more than 1 month during last 3 months before the study
  • history of acute or chronic disease such as severe liver or kidney disease
  • history of allergies against any component of trial foods
  • any visible skin disease that might be confused with a skin reaction to the test procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

Location

MeSH Terms

Interventions

Isoflavonesastaxanthine

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Jin Ho Chung, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 20, 2015

First Posted

February 26, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

June 14, 2016

Record last verified: 2016-06

Locations

KR(1)