Oral Supplementation of Astaxanthin on Skin Photoaging, H... | NCT05882084

Studies
Oral Supplementation of Astaxanthin on Skin Photoaging, Hydration and Elasticity

NCT05882084

Sponsor

Integrative Skin Science and Research

Status

Unknown status

Last Update Posted

Jul 25, 2023Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Photoaging

Interventions

Astaxanthin 6 mg daily
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2023Actual

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

May 21, 2023

First Submission Date that Met QC Criteria

May 21, 2023

First Posted Date

May 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2023

Last Update Posted Date

Jul 25, 2023Actual

Name	Class
AstaReal	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Astaxanthin	Experimental	6 mg daily	Dietary Supplement: Astaxanthin 6 mg daily
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Astaxanthin 6 mg daily	Dietary Supplement	Astaxanthin at 6 mg is given for daily ingestion and compared against placebo.	Astaxanthin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Raja Sivamani, MD	Contact	916-524-1216		research@integrativeskinresearch.com

Overall Officials

Name	Affiliation	Role
Raja Sivamani, MD	Integrative Skin Science and Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Integrative Skin Science and Research	Recruiting	Sacramento	California	95819	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided