WrinkleNCT05231681
Study to Identify if Saie Beauty's Under Eye Concealer Works to Improve Under-Eye Skin Appearance and Reduce Imperfections
A study testing Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer in people with Wrinkle, run by Saie Beauty at 1 site in United States.
Trial summary
Saie Beauty has developed 'Hydrabeam Sheer Brightening Under Eye Concealer' that is specifically designed for improving under-eye skin health. The concealer is aimed at improving under-eye skin features including hydration, firmness/elasticity, smoothness, and brightness. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkle
- What is being tested?
- Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 1 May 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female between 18 and 45 years old
- Must be in good general health
- Want to improve under-eye skin health by improving skin hydration, firmness/elasticity, smoothness, and brightness
- May have dark circles, fine lines, wrinkles, and crow's feet
- Must be willing to comply with the study protocol
- Must be willing to add the concealer to their daily routine for the duration of the study
Show all 10Show fewer
- Must maintain a basic skincare routine, e.g., must use moisturizer and sunscreen daily
- Able to communicate in English
- Must provide a written Informed Consent Form (ICF)
- Willing to share feedback via the given online portal
Who cannot join
- Unwilling to follow the routine of the study
- Unwilling to provide informed consent
- Currently participating in another research study
- Severe chronic conditions including ontological and psychiatric conditions
- Use of prescription medication relevant for the skin
- Have any known allergies to the ingredients of the test product
Show all 12Show fewer
- Known to have any severe allergic reactions in the past
- Undergoing any cosmetic procedures such as laser treatments, Botox, or chemical peels for the duration of the study.
- Have diagnosed or self-identified sensitive skin
- Have any learning and/or cognitive difficulties that prevent them from reading and understanding questionnaires and surveys (e.g. dementia)
- Currently pregnant or breastfeeding, or want to become pregnant for the duration of the study
- Use of prescription drugs (topical or oral) that are targeted at any sort of skin condition (for example retinoids)
Trial locations and contacts
1 site in 1 country.
About this study
Saie Beauty has developed 'Hydrabeam Sheer Brightening Under Eye Concealer' that is specifically designed for improving under-eye skin health. The concealer is aimed at improving under-eye skin features including hydration, firmness/elasticity, smoothness, and brightness. At the same time, it is aimed at reducing imperfections such as dark circles, skin redness, fine lines, wrinkles, and crow's feet. The aim is to understand and assess the efficacy of treatment from the participants' perspective and to see if the participants reported changes in skin features, dark circles, brightness, fine lines, wrinkles, crow's feet, and other skin imperfections.
- Conditions
- Wrinkle
- Being tested
- Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer
- Keywords
- skin aging, fine lines, crow's feet, dark circles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saie Beauty's Hydrabeam Sheer Brightening Under Eye ConcealerDietary supplement
Eye Concealer
| Study group | Role | What they receive |
|---|---|---|
| Eye Concealer | Experimental | Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer Receives: Dietary Supplement: Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin aging [Time frame: Baseline to 4 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 brighter skin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start15 Feb 2022
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinkleStudies 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
- Model description
- This is an open-label single-group, non-randomized, non-controlled interventional treatment study.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saie Beauty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susanne Mitschke, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231681
- Sponsor's protocol ID
- 20231Saie
- Status last verified
- May 2022
- First submitted
- 31 Jan 2022
- Last updated
- 6 May 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 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Identify if Saie Beauty's Under Eye Concealer Works to Improve Under-Eye Skin Appearance and Reduce Imperfections
- ClinicalTrials.gov ID
- NCT05231681
- Acronym / sponsor ID
- 20231Saie
- Conditions
- Wrinkle
- Keywords
- skin aging, fine lines, crow's feet, dark circles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Saie BeautyIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Feb 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.
Saie Beauty has developed 'Hydrabeam Sheer Brightening Under Eye Concealer' that is specifically designed for improving under-eye skin health. The concealer is aimed at improving under-eye skin features including hydration, firmness/elasticity, smoothness, and brightness. At the same time, it is aimed at reducing imperfections such as dark circles, skin redness, fine lines, wrinkles, and crow's feet. The aim is to understand and assess the efficacy of treatment from the participants' perspective and to see if the participants reported changes in skin features, dark circles, brightness, fine lines, wrinkles, crow's feet, and other skin imperfections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label single-group, non-randomized, non-controlled interventional treatment study.
| Arm | Type | Receives |
|---|---|---|
| Eye Concealer | Experimental | Dietary Supplement: Saie Beauty's Hydrabeam Sheer Brightening Under Eye ConcealerSaie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female between 18 and 45 years old
- Must be in good general health
- Want to improve under-eye skin health by improving skin hydration, firmness/elasticity, smoothness, and brightness
- May have dark circles, fine lines, wrinkles, and crow's feet
- Must be willing to comply with the study protocol
Key exclusion criteria (12 listed)
- Unwilling to follow the routine of the study
- Unwilling to provide informed consent
- Currently participating in another research study
- Severe chronic conditions including ontological and psychiatric conditions
- Use of prescription medication relevant for 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 |
|---|---|---|
| Saie Beauty's Hydrabeam Sheer Brightening Under Eye ConcealerEye Concealer | Dietary supplement | Eye Concealer |
Primary outcome
Skin aging [Time frame: Baseline to 4 weeks]
Time frame: 4 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 brighter skin
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 6 May 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Wrinkle
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
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.
Susanne Mitschke principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer in people with Wrinkle, run by Saie Beauty 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 12 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 6 May 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?
Skin aging [Time frame: Baseline to 4 weeks] (time frame: 4 weeks). 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 6 May 2022.