AcneNCT05319847
An Exploratory Investigation of a Male Focused Skincare Supplement
A study testing Daily Skin Supplement - Fountain of Youth in people with Acne and Skin Abnormalities, run by Let's Disco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Acne, Skin Abnormalities
- What is being tested?
- Daily Skin Supplement - Fountain of Youth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acne, Skin Abnormalities
- Being tested
- Daily Skin Supplement - Fountain of Youth
- Medical subject headings
- Acne Vulgaris, Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily Skin Supplement - Fountain of YouthDietary supplement
Skincare supplement
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Daily Skin Supplement - Fountain of Youth Receives: Dietary Supplement: Daily Skin Supplement - Fountain of Youth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start15 Apr 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Let's Disco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319847
- Sponsor's protocol ID
- 20239Disco
- Status last verified
- Sep 2022
- First submitted
- 31 Mar 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of a Male Focused Skincare Supplement
- ClinicalTrials.gov ID
- NCT05319847
- Acronym / sponsor ID
- 20239Disco
- Conditions
- Acne, Skin Abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Let's DiscoIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Dietary Supplement: Daily Skin Supplement - Fountain of YouthDaily Skin Supplement - Fountain of Youth |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily Skin Supplement - Fountain of YouthSkincare supplement | Dietary supplement | Intervention arm |
Primary outcome
Adult Acne
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily Skin Supplement - Fountain of Youth in people with Acne and Skin Abnormalities, run by Let's Disco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adult Acne (time frame: 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.