Study To Investigate If Embody's Retinol Gummies Improve... | NCT04884516

Studies
Study To Investigate If Embody's Retinol Gummies Improve The Early Signs Of Skin Aging And Overall Skin Health

NCT04884516

Sponsor

Embody Beauty, Inc.

Status

Completed

Last Update Posted

May 13, 2021Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Acne, Adult

Interventions

Retinol gummy

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 2021

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

Jan 19, 2021Actual

Primary Completion Date

Apr 15, 2021Actual

Completion Date

Apr 15, 2021Actual

First Submitted Date

May 6, 2021

First Submission Date that Met QC Criteria

May 11, 2021

First Posted Date

May 13, 2021Actual

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 11, 2021

Last Update Posted Date

May 13, 2021Actual

Name	Class
Citruslabs	INDUSTRY

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

The Embody retinol study is a single-arm clinical trial on skin aging prevention and adult acne. The purpose of this study is to determine the effect of a retinol gummy in adults aged 18-45 on skin aging and overall skin health.

Detailed Description

Embody has developed a retinol gummy with the aim to improve the appearance of early signs of aging, such as fine lines, dark spots, and sagging. Embody's retinol gummy has also the goal to reduce the overall frequency of adult acne and an improvement of overall skin health by promoting hydrated, brightened skin. The study aims to collect self-reported outcomes and photographic images to understand the assessment of the efficacy of treatment from the participant's perspective, and if participants see an improvement in their fine lines, wrinkles, dark spots, and sagging.

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
Intervention arm	Other	Participants take retinol gummy once a day	Dietary Supplement: Retinol gummy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retinol gummy	Dietary Supplement	Participants take one retinol gummy per day	Intervention arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Skin aging [Time frame: Baseline to 8 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 sagging	8 week intervention period
Adult acne [Time frame: Baseline to 8 weeks]	Reduction the overall frequency and intensity of adult acne (Scale 0-5 with higher scores representing a reduction in the appearance of adult acne)	8 week intervention period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female between 18-45 years old
Must be in good general health
May experiences adult acne and/or early-stage wrinkles that are not treated by topical or oral prescription drugs/medication
Must maintain a basic skincare routine
Must discontinue the use of other dietary supplements
Must be willing to comply with the requirements of the protocol
Is able to communicate in English
Is willing to skip their normal skincare routine
Must provide written informed consent form (ICF)
Is willing and able to share feedback and take skin pictures via the used technology portal

Exclusion Criteria:

Unwilling to provide consent
Unwilling to skip their normal skincare routine
Unwilling to follow the routine of the protocol
Use of other oral retinoids
Use of prescription medication relevant to the skin
Undergoing any cosmetic procedures during the study including Botox, laser or chemical treatments
Deep-set of wrinkles
History of the following medical conditions or diseases:
Kidney disease
Liver disease
Alcohol abuse
Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (for example retinoids)
Any known allergies/sensitivities to nuts

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
C565791	Acne, Adult
D000152	Acne Vulgaris

Ancestor Terms

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

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Browse Branches

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