Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity

Sponsor

Integrative Skin Science and Research (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05882084

Collaborator

AstaReal (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Photoaging	Dietary Supplement: Astaxanthin 6 mg daily Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Astaxanthin vs PlaceboAstaxanthin vs Placebo

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Astaxanthin

6 mg daily

Dietary Supplement: Astaxanthin 6 mg daily

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

Placebo Comparator: Placebo

Dietary Supplement: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Skin Hydration [8 weeks]
Skin hydration measured with a non-invasive device, SkinMoistureMeterSC
Skin elasticity [8 weeks]
Skin elasticity measured with a non-invasive device, Skin Elastimeter

Secondary Outcome Measures

Facial pigmentation [8 weeks]
Facial pigment as measured by BTBP facial imaging analysis
Facial redness [8 weeks]
Facial pigment as measured by BTBP facial imaging analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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