Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity

July 24, 2023 updated by: Raja Sivamani, MD MS AP, Integrative Skin Science and Research

Double Blind Placebo Controlled Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

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 Contact

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo
Experimental: Astaxanthin
6 mg daily
Dietary supplement: Astaxanthin 6 mg daily
Astaxanthin at 6 mg is given for daily ingestion and compared against placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Hydration
Time Frame: 8 weeks
Skin hydration measured with a non-invasive device, SkinMoistureMeterSC
8 weeks
Skin elasticity
Time Frame: 8 weeks
Skin elasticity measured with a non-invasive device, Skin Elastimeter
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Facial pigmentation
Time Frame: 8 weeks
Facial pigment as measured by BTBP facial imaging analysis
8 weeks
Facial redness
Time Frame: 8 weeks
Facial pigment as measured by BTBP facial imaging analysis
8 weeks

Collaborators and Investigators

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

Sponsor

Integrative Skin Science and Research

Collaborators

AstaReal

Investigators

  • Principal Investigator: Raja Sivamani, MD, Integrative Skin Science and Research

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 (Actual)

July 24, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

May 21, 2023

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asta_Skin_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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