An Exploratory Investigation of a Male Focused Skincare Supplement
Primary Purpose
Acne, Skin Abnormalities
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily Skin Supplement - Fountain of Youth
Sponsored by
About this trial
This is an interventional treatment trial for Acne
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
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Daily Skin Supplement - Fountain of Youth
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT05319847
First Posted
March 31, 2022
Last Updated
September 22, 2022
Sponsor
Let's Disco
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05319847
Brief Title
An Exploratory Investigation of a Male Focused Skincare Supplement
Official Title
An Exploratory Investigation of a Male Focused Skincare Supplement
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Let's Disco
Collaborators
Citruslabs
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne, Skin Abnormalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label, Single Group Design
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Daily Skin Supplement - Fountain of Youth
Intervention Type
Dietary Supplement
Intervention Name(s)
Daily Skin Supplement - Fountain of Youth
Intervention Description
Skincare supplement
Primary Outcome Measure Information:
Title
Adult Acne
Description
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)
Time Frame
12 week
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
An Exploratory Investigation of a Male Focused Skincare Supplement
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