Clinical trial NCT05231681: Study to Identify if Saie Beauty's Under Eye Concealer Works to Improve Under-Eye Skin Appearance and Reduce Imperfections
Official title: Study to Identify if Saie Beauty's Under Eye Concealer Works to Improve Under-Eye Skin Appearance and Reduce Imperfections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Keywords: skin aging
fine lines
crow's feet
dark circles
Lead sponsor: Saie Beauty
Sponsor class: INDUSTRY
First posted: 2022-02-09
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label single-group, non-randomized, non-controlled interventional treatment study.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Skin aging [Time frame: Baseline to 4 weeks]
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Susanne Mitschke
role: PRINCIPAL_INVESTIGATOR
References: