Clinical trial NCT06125912: A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin Aging
Official title: A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Lead sponsor: Dime Beauty Co.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-11-09
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate the efficacy of the DIME TBT Cream in improving the appearance and hydration of aged skin in comparison to a retinol cream. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use both the test product and the positive control product (0.1% Retinol Clinical Trial Lotion). Participants will be required to undertake questionnaires at Baseline, Day 30, and Day 60. Photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.


Eligibility criteria: Inclusion Criteria:

Females aged 18-65. Have one or more of the following: visible fine lines and wrinkles, dry skin, reduced skin elasticity, or generally unhealthy skin.

Must be willing to use two different skincare products, one on each side of their face for the duration of the trial.

Have a smartphone or camera to take before-and-after selfies.

Exclusion Criteria:

Anyone not in good health. Anyone who has any chronic health conditions such as oncological or psychiatric disorders.

Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.

Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.

Anyone who cannot/ will not commit to the study protocol. Anyone with a history of substance abuse.

Primary outcomes:
measure: Change in the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
timeFrame: 60 days
measure: Change in participants' perception of the appearance of fine lines and wrinkles on the face. [Baseline to Day 60]
timeFrame: 60 days
measure: Change in skin elasticity. [Baseline to Day 60]
timeFrame: 60 days
measure: Changes in signs of skin aging. [Baseline to Day 60]
timeFrame: 60 days
measure: Changes in participants' perception of signs of skin aging. [Baseline to Day 60]
timeFrame: 60 days
measure: Changes in participants' perception of facial skin hydration. [Baseline to Day 60]
timeFrame: 60 days
measure: Changes in facial skin hydration. [Baseline to Day 60]
timeFrame: 60 days
Secondary outcomes:
measure: Comparison of the visual changes in the signs of skin aging as a result of using the test product compared to the control product. [Baseline to Day 60]
timeFrame: 60 days
measure: Comparison of participants perception of the visual changes in the signs of skin aging as a result of using the test product compared to the control product. [Baseline to Day 60]
timeFrame: 60 days
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: