Effects of Isoflavone Combined With Astaxanthin on Skin Aging

June 11, 2016 updated by: Jin Ho Chung, Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Isoflavone and Astaxanthin
Each subject takes one active tablet per day for 24 weeks. Each tablet contains isoflavone 27mg and astaxanthin 4mg.
Dietary supplement: Astaxanthin
Dietary supplement: Isoflavone
Placebo Comparator: Placebo
Each subject takes one placebo tablet per day for 24 weeks.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in skin wrinkles
Time Frame: Twenty-four weeks
Facial wrinkles in the crow's feet area measured by Skin Visiometer
Twenty-four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in skin elasticity
Time Frame: Twenty-four weeks
Facial elasticity measured by Cutometer
Twenty-four weeks
Change from baseline in epidermal hydration
Time Frame: Twenty-four weeks
Skin hydration measured by Corneometer
Twenty-four weeks
Change from baseline in skin barrier integrity
Time Frame: Tewnty-four weeks
TEWL measured by Tewameter
Tewnty-four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jin Ho Chung, MD, PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 11, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-1412-144-637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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