- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05231681
Study to Identify if Saie Beauty's Under Eye Concealer Works to Improve Under-Eye Skin Appearance and Reduce Imperfections
May 4, 2022 updated by: Saie Beauty
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Santa Monica, California, United States, 90404
- Citruslabs
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Eye Concealer
Saie Beauty's Hydrabeam Sheer Brightening Under Eye Concealer
|
Eye Concealer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 15, 2022
Primary Completion (ACTUAL)
May 1, 2022
Study Completion (ACTUAL)
May 1, 2022
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
January 31, 2022
First Posted (ACTUAL)
February 9, 2022
Study Record Updates
Last Update Posted (ACTUAL)
May 6, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20231Saie
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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