Examining the Efficacy of a Novel Moisturizer Across Eight Weeks

Skin Health Clinical Trial

Official title:

Examining the Efficacy of a Novel Moisturizer Across Eight Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861622
• Other study ID #: 20257
• Status: Completed
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: May 2023
• Source: Thu Brulé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Skin Health

Intervention

Other:
• Moisturizer
The test product is a novel moisturizer, that contains active ingredients, including rambutan extract, niacinamide, and glycoin.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Thu Brulé	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived changes in skin health	Survey based assessment of participants perceived skin health. Data was collected using a textual 5-point Likert scale for each question, such as "Not noticeable" to "severe." Symptom-related questions were conducted at baseline and each check-in. The textual Likert data was transformed into numerical values of 1-6, with 6 representing the most beneficial response (i.e, "not noticeable" response to the question, "how would you rate the severity of your wrinkles") and 1 representing the least favorable/worse outcome ("severe").	Week 8
Primary	Changes in skin health via VISIA® imaging	VISIA® Skin Analysis system will be used to assess changes in skin outcomes. Analysis will be conducted by a board-certified dermatologist at Baseline and Week 8. The VISIA® Skin Analysis system will be used to capture the images which will then be processed by the VISIA software. The software utilizes advanced algorithms to detect and measure specific skin attributes. The skin attributes/parameters evaluated will be Wrinkles, Spots, Pores, Texture, Redness and UV Damage. These parameters are evaluated using the captured images and the specialized algorithms employed by the VISIA software. The results are then used to generate a comprehensive analysis report, which includes both the quantitative measurements and qualitative assessments, along with any corresponding scores or ratings assigned to different skin attributes. Mean participant's scores for each parameter will be calculated at Baseline and Week 8 and compared for statistical significance.	Baseline to Week 8