An Exploratory Investigation of a Male Focused Skincare S... | NCT05319847

Studies
An Exploratory Investigation of a Male Focused Skincare Supplement

NCT05319847

Sponsor

Let's Disco

Status

Completed

Last Update Posted

Sep 26, 2022Actual

Enrollment

38Actual

Phase

Not Applicable

Conditions

Acne
Skin Abnormalities

Interventions

Daily Skin Supplement - Fountain of Youth

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

Sep 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

Apr 15, 2022Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Mar 31, 2022

First Submission Date that Met QC Criteria

Mar 31, 2022

First Posted Date

Apr 8, 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

Sep 22, 2022

Last Update Posted Date

Sep 26, 2022Actual

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

Most skincare products on the market are topical and do not take a holistic approach to understanding skin health. This trial will examine a dietary supplement designed to support the gut microbiome and promote skin health from an internal perspective. Research has previously supported the link between the gut microbiome and skin health and the supplement tested in this trial will further the knowledge on the effectiveness of supporting gut health to improve skin outcomes.

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

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention arm	Experimental	Daily Skin Supplement - Fountain of Youth	Dietary Supplement: Daily Skin Supplement - Fountain of Youth

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daily Skin Supplement - Fountain of Youth	Dietary Supplement	Skincare supplement	Intervention arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adult Acne	Change in overall frequency and intensity of adult acne (Likert Scale 0-5 with higher scores representing a reduction in the appearance of adult acne)	12 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male
Between the ages of 18-55
Frequently experience different forms of acne
Frequently experience breakouts
Must be in good health with no long term health conditions
BMI must be under 40
Must follow a consistent dietary regimen
Must be willing to stop any oral supplementation targeting their skin while in the trail

Exclusion Criteria:

Anyone who does take prescription medication (oral or topical) targeting their skin including reinoid, over the counter retinol, or retinal
Not willing to stop any oral supplementation targeting their skin
Severe chronic conditions, including oncological and psychiatric disorders
Previous severe allergic reactions
Unwilling the follow the study protocol

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D000152	Acne Vulgaris
D012868	Skin Abnormalities

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided