NCT05882084

Brief Summary

This study is a double-blind placebo controlled study to assess whether oral astaxanthin can improve skin hydration, skin elasticity, improve skin pigmentation, and reduce facial redness.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 21, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 24, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

May 21, 2023

Last Update Submit

July 24, 2023

Conditions

Keywords

CarotenoidAstaxanthinSkinHydrationElasticity

Outcome Measures

Primary Outcomes (2)

  • Skin Hydration

    Skin hydration measured with a non-invasive device, SkinMoistureMeterSC

    8 weeks

  • Skin elasticity

    Skin elasticity measured with a non-invasive device, Skin Elastimeter

    8 weeks

Secondary Outcomes (2)

  • Facial pigmentation

    8 weeks

  • Facial redness

    8 weeks

Study Arms (2)

Astaxanthin

EXPERIMENTAL

6 mg daily

Dietary Supplement: Astaxanthin 6 mg daily

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Astaxanthin 6 mg dailyDIETARY_SUPPLEMENT

Astaxanthin at 6 mg is given for daily ingestion and compared against placebo.

Astaxanthin
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females who are 30 to 55 years of age
  • Half of the women will have Fitzpatrick skin type 1-3 and the other half of the women will have Fitzpatrick skin type 4-6

You may not qualify if:

  • Individuals with a known allergy to astaxanthin or other carotenoids (such as zeaxanthin, lutein, lycopene).
  • Individuals who are unwilling to discontinue carotenoid supplementation for at least 1 month prior to enrollment
  • Individuals unwilling to restrict intake of foods like shrimp, salmon, mangos, carrots, and tomatoes during the study.
  • New supplementation within 4 weeks with tocopherol
  • Individuals who are unwilling to stay consistent with a facial cleansing regimen.
  • Those who are unwilling to discontinue topical hydroquinone, retinoid or benzoyl peroxide for 2 weeks prior to enrollment
  • Individuals who are pregnant or breastfeeding.
  • Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.
  • Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrative Skin Science and Research

Sacramento, California, 95819, United States

RECRUITING

MeSH Terms

Interventions

astaxanthine

Study Officials

  • Raja Sivamani, MD

    Integrative Skin Science and Research

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Astaxanthin vs Placebo
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2023

First Posted

May 31, 2023

Study Start

July 24, 2023

Primary Completion

September 30, 2023

Study Completion

December 31, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations