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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05882084
Other study ID # Asta_Skin_01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 24, 2023
Est. completion date December 31, 2023

Study information

Verified date July 2023
Source Integrative Skin Science and Research
Contact Raja Sivamani, MD
Phone 916-524-1216
Email research@integrativeskinresearch.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Astaxanthin 6 mg daily
Astaxanthin at 6 mg is given for daily ingestion and compared against placebo.
Placebo
Placebo

Locations

Country Name City State
United States Integrative Skin Science and Research Sacramento California

Sponsors (2)

Lead Sponsor Collaborator
Integrative Skin Science and Research AstaReal

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Skin Hydration Skin hydration measured with a non-invasive device, SkinMoistureMeterSC 8 weeks
Primary Skin elasticity Skin elasticity measured with a non-invasive device, Skin Elastimeter 8 weeks
Secondary Facial pigmentation Facial pigment as measured by BTBP facial imaging analysis 8 weeks
Secondary Facial redness Facial pigment as measured by BTBP facial imaging analysis 8 weeks
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