Clinical trial NCT05861622: Examining the Efficacy of a Novel Moisturizer Across Eight Weeks
Official title: Examining the Efficacy of a Novel Moisturizer Across Eight Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Health
Lead sponsor: Thu Brulé
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-05-17
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Skin moisture is critical to avoid long-term skin damage. Without the necessary moisture, skin is unlikely to have the properties most commonly associated with healthy skin. Recent research has recently highlighted that rambutan extract, niacinamide, and glycoin can all help promote skin moisture and health. To help people experience better skin health, Thu Brulé has developed a serum designed to be used twice daily. Specifically, the test product in this trial was designed to help moisturize the skin and help lock in that moisture. The purpose of this trial is to examine the efficacy of the test product across an eight-week hybrid trial. The outcomes of interest include participants' perceptions of skin health and photographs/images taken of the skin.


Eligibility criteria: Inclusion Criteria:

* Male or female between the ages of 30-80.
* Frequently experience dry skin.
* Must experience early-stage wrinkles that are not treated by topical or oral prescription drugs/medication or over-the-counter products (e.g., Adapalene/Differin)
* Must be in good health with no unstable, uncontrolled health conditions.
* Must follow a stable, consistent dietary regimen.
* May experience hyperpigmentation and dark spots.
* Must be willing to maintain the following daily skincare routine: Daily cleansing, test product, and sunscreen that is at least SPF 30
* Must discontinue retinoids four weeks before the study start date and not use retinoids during the trial.
* Must be willing to communicate in English.
* Must be willing to use the test product as directed (twice daily)
* Must be willing to come to the Citruslabs office in Santa Monica, California at the beginning and end of the study.

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Currently participating in another research study.
* Currently using oral retinoids.
* Individuals with self-reported very oily skin.
* Individuals with cystic acne or otherwise very acne-prone skin.
* Anyone using oral acne treatments (e.g., accutane).
* Anyone prone to experiencing strong bouts of hormonal acne.
* Anyone using prescription medication relevant to the skin.
* Undergoing any cosmetic procedures during the study, including Botox, laser, or chemical peel treatments.
* Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (e.g., retinoids)
* Anyone with learning and/or cognitive difficulties that prevent him/her from reading and understanding questionnaires and surveys (e.g., dementia)
* Severe chronic conditions, including oncological conditions or psychiatric disorders.

Primary outcomes:
measure: Perceived changes in skin health
timeFrame: Week 8
measure: Changes in skin health via VISIA® imaging
timeFrame: Baseline to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: