An Exploratory Investigation of a Male Focused Skincare Supplement

• Sponsor: Let's Disco (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05319847
• Collaborator: Citruslabs (Industry)
• Enrollment: 38
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.5
• Patients Per Site Per Month: 15.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acne; Skin Abnormalities	Dietary Supplement: Fountain of Youth skincare supplement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Open Label, Single Group Design
• Primary Purpose: Treatment
• Official Title: An Exploratory Investigation of a Male Focused Skincare Supplement
• Actual Study Start Date: Apr 15, 2022
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm Fountain of Youth skincare supplement	Dietary Supplement: Fountain of Youth skincare supplement; Skincare supplement

Outcome Measures

Primary Outcome Measures

1. Adult Acne [12 week]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

• Let's Disco
• Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Let's Disco
• ClinicalTrials.gov Identifier: NCT05319847
• Other Study ID Numbers: 20239Disco
• First Posted: Apr 8, 2022
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Skin Abnormalities

Study Results

No Results Posted as of Aug 18, 2022