Study to Identify if Saie Beauty's Under Eye Concealer Wo... | NCT05231681

Studies
Study to Identify if Saie Beauty's Under Eye Concealer Works to Improve Under-Eye Skin Appearance and Reduce Imperfections

NCT05231681

Sponsor

Saie Beauty

Status

Completed

Last Update Posted

May 6, 2022Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Wrinkle

Interventions

Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer

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

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

May 1, 2022Actual

Completion Date

May 1, 2022Actual

First Submitted Date

Jan 31, 2022

First Submission Date that Met QC Criteria

Jan 31, 2022

First Posted Date

Feb 9, 2022Actual

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

May 4, 2022

Last Update Posted Date

May 6, 2022Actual

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

Saie Beauty has developed 'Hydrabeam Sheer Brightening Under Eye Concealer' that is specifically designed for improving under-eye skin health. The concealer is aimed at improving under-eye skin features including hydration, firmness/elasticity, smoothness, and brightness. At the same time, it is aimed at reducing imperfections such as dark circles, skin redness, fine lines, wrinkles, and crow's feet. The aim is to understand and assess the efficacy of treatment from the participants' perspective and to see if the participants reported changes in skin features, dark circles, brightness, fine lines, wrinkles, crow's feet, and other skin imperfections.

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

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eye Concealer	Experimental	Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer	Dietary Supplement: Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer	Dietary Supplement	Eye Concealer	Eye Concealer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin aging [Time frame: Baseline to 4 weeks]	Patient reported outcome measures (Scale 0-5 with higher scores representing a better outcome) to assess the reduction of early signs of aging such as fine lines, dark spots, and brighter skin	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female between 18 and 45 years old
Must be in good general health
Want to improve under-eye skin health by improving skin hydration, firmness/elasticity, smoothness, and brightness
May have dark circles, fine lines, wrinkles, and crow's feet
Must be willing to comply with the study protocol
Must be willing to add the concealer to their daily routine for the duration of the study
Must maintain a basic skincare routine, e.g., must use moisturizer and sunscreen daily
Able to communicate in English
Must provide a written Informed Consent Form (ICF)
Willing to share feedback via the given online portal

Exclusion Criteria:

Unwilling to follow the routine of the study
Unwilling to provide informed consent
Currently participating in another research study
Severe chronic conditions including ontological and psychiatric conditions
Use of prescription medication relevant for the skin
Have any known allergies to the ingredients of the test product
Known to have any severe allergic reactions in the past
Undergoing any cosmetic procedures such as laser treatments, Botox, or chemical peels for the duration of the study.
Have diagnosed or self-identified sensitive skin
Have any learning and/or cognitive difficulties that prevent them from reading and understanding questionnaires and surveys (e.g. dementia)
Currently pregnant or breastfeeding, or want to become pregnant for the duration of the study
Use of prescription drugs (topical or oral) that are targeted at any sort of skin condition (for example retinoids)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Based on gender identity

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Susanne Mitschke	Citruslabs	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Citruslabs		Santa Monica	California	90404	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided