Acne, AdultNCT04884516
Study To Investigate If Embody's Retinol Gummies Improve The Early Signs Of Skin Aging And Overall Skin Health
A study testing Retinol gummy in people with Acne, Adult, run by Embody Beauty, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Adult
- What is being tested?
- Retinol gummy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 15 Apr 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Identify if Embody's Retinol Gummy Works to Improve the Appearance of Early Signs of Aging and to Examine if it Reduces the Overall Frequency and Intensity of Adult Acne.
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.
Read the 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.
- Conditions
- Acne, Adult
- Being tested
- Retinol gummy
- Keywords
- skin aging, adult acne
- Medical subject headings
- Acne, Adult, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinol gummyDietary supplement
Participants take one retinol gummy per day
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Other | Participants take retinol gummy once a day Receives: Dietary Supplement: Retinol gummy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 8 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start19 Jan 2021
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne, AdultStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Embody Beauty, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884516
- Sponsor's protocol ID
- EmbodyRetinol
- Status last verified
- May 2021
- First submitted
- 6 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Identify if Embody's Retinol Gummy Works to Improve the Appearance of Early Signs of Aging and to Examine if it Reduces the Overall Frequency and Intensity of Adult Acne.
- ClinicalTrials.gov ID
- NCT04884516
- Acronym / sponsor ID
- EmbodyRetinol
- Conditions
- Acne, Adult
- Keywords
- skin aging, adult acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Embody Beauty, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 13 May 2021 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Dietary Supplement: Retinol gummyParticipants take retinol gummy once a day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Retinol gummyParticipants take one retinol gummy per day | Dietary supplement | Intervention arm |
Primary outcome
Skin aging [Time frame: Baseline to 8 weeks]
Time frame: 8 week intervention period
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
Adult acne [Time frame: Baseline to 8 weeks]
Time frame: 8 week intervention period
Reduction the overall frequency and intensity of adult acne (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 13 May 2021.
- Individual participant dataSharing planned: No
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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 Retinol gummy in people with Acne, Adult, run by Embody Beauty, Inc. 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 10 inclusion and 13 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 13 May 2021. 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?
Skin aging [Time frame: Baseline to 8 weeks] (time frame: 8 week intervention period). The study lists 2 primary outcomes in all. 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 13 May 2021.