Back to resultsOral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
Primary Purpose
Photoaging
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Astaxanthin 6 mg daily
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Photoaging focused on measuring Carotenoid, Astaxanthin, Skin, Hydration, Elasticity
Eligibility Criteria
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
Sites / Locations
- Integrative Skin Science and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Astaxanthin
Placebo
Arm Description
6 mg daily
Outcomes
Primary Outcome Measures
Skin Hydration
Skin hydration measured with a non-invasive device, SkinMoistureMeterSC
Skin elasticity
Skin elasticity measured with a non-invasive device, Skin Elastimeter
Secondary Outcome Measures
Facial pigmentation
Facial pigment as measured by BTBP facial imaging analysis
Facial redness
Facial pigment as measured by BTBP facial imaging analysis
Full Information
NCT ID
NCT05882084
First Posted
May 21, 2023
Last Updated
July 24, 2023
Sponsor
Integrative Skin Science and Research
Collaborators
AstaReal
1. Study Identification
Unique Protocol Identification Number
NCT05882084
Brief Title
Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
Official Title
Double Blind Placebo Controlled Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Integrative Skin Science and Research
Collaborators
AstaReal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoaging
Keywords
Carotenoid, Astaxanthin, Skin, Hydration, Elasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Astaxanthin vs Placebo
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Astaxanthin
Arm Type
Experimental
Arm Description
6 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Astaxanthin 6 mg daily
Intervention Description
Astaxanthin at 6 mg is given for daily ingestion and compared against placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Skin Hydration
Description
Skin hydration measured with a non-invasive device, SkinMoistureMeterSC
Time Frame
8 weeks
Title
Skin elasticity
Description
Skin elasticity measured with a non-invasive device, Skin Elastimeter
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Facial pigmentation
Description
Facial pigment as measured by BTBP facial imaging analysis
Time Frame
8 weeks
Title
Facial redness
Description
Facial pigment as measured by BTBP facial imaging analysis
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raja Sivamani, MD
Phone
916-524-1216
Email
research@integrativeskinresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raja Sivamani, MD
Organizational Affiliation
Integrative Skin Science and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Skin Science and Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nasima Afzal
Phone
916-750-2463
Email
nasima@integrativeskinresearch.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity
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