AgeingNCT02373111
Effects of Isoflavone Combined With Astaxanthin on Skin Aging
A study testing Isoflavone and Astaxanthin in people with Ageing and Photo-aging, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ageing, Photo-aging
- What is being tested?
- Isoflavone and Astaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy females aged ≥ 45 years
- Facial wrinkle grade 2 to 4
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Ageing, Photo-aging
- Being tested
- Isoflavone, Astaxanthin, Placebo
- Keywords
- Anti-aging, Isoflavones, Astaxanthine, Skin aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsoflavoneDietary supplement
AstaxanthinDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Isoflavone and Astaxanthin | Active comparator | Each subject takes one active tablet per day for 24 weeks. Each tablet contains isoflavone 27mg and astaxanthin 4mg. Receives: Dietary Supplement: Isoflavone; Dietary Supplement: Astaxanthin |
| Placebo | Placebo comparator | Each subject takes one placebo tablet per day for 24 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in skin wrinkles
Facial wrinkles in the crow's feet area measured by Skin Visiometer
Measured: Twenty-four weeks
Secondary outcomes (3)
Change from baseline in skin elasticity
Facial elasticity measured by Cutometer
Measured: Twenty-four weeks
Change from baseline in epidermal hydration
Skin hydration measured by Corneometer
Measured: Twenty-four weeks
Change from baseline in skin barrier integrity
TEWL measured by Tewameter
Measured: Tewnty-four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Ho Chung, Seoul National University Hospital
- Investigators
- Jin Ho Chung, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373111
- Sponsor's protocol ID
- H-1412-144-637
- Status last verified
- Jun 2016
- First submitted
- 20 Feb 2015
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isoflavone Combined With Astaxanthin on Skin Aging
- ClinicalTrials.gov ID
- NCT02373111
- Acronym / sponsor ID
- H-1412-144-637
- Conditions
- Ageing, Photo-aging
- Keywords
- Anti-aging, Isoflavones, Astaxanthine, Skin aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Feb 2015 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isoflavone and Astaxanthin | Active comparator | Dietary Supplement: Isoflavone, Dietary Supplement: AstaxanthinEach subject takes one active tablet per day for 24 weeks. Each tablet contains isoflavone 27mg and astaxanthin 4mg. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboEach subject takes one placebo tablet per day for 24 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy females aged ≥ 45 years
- Facial wrinkle grade 2 to 4
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Isoflavone | Dietary supplement | Isoflavone and Astaxanthin |
| Astaxanthin | Dietary supplement | Isoflavone and Astaxanthin |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change from baseline in skin wrinkles
Time frame: Twenty-four weeks
Facial wrinkles in the crow's feet area measured by Skin Visiometer
3 secondary outcomes
Change from baseline in skin elasticity
Time frame: Twenty-four weeks
Change from baseline in epidermal hydration
Time frame: Twenty-four weeks
Change from baseline in skin barrier integrity
Time frame: Tewnty-four weeks
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 14 Jun 2016.
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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.
Jin Ho Chung, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflavone and Astaxanthin in people with Ageing and Photo-aging, run by Seoul National University Hospital at 1 site in South Korea.
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 2 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 14 Jun 2016. 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 South Korea. 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?
Change from baseline in skin wrinkles (time frame: Twenty-four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2016.