Clinical trial NCT04884516: Study To Investigate If Embody's Retinol Gummies Improve The Early Signs Of Skin Aging And Overall Skin Health
Official title: Study to Identify if Embody's Retinol Gummy Works to Improve the Appearance of Early Signs of Aging and to Examine if it Reduces the Overall Frequency and Intensity of Adult Acne.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne, Adult
Keywords: skin aging
adult acne
Lead sponsor: Embody Beauty, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2021-05-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Embody retinol study is a single-arm clinical trial on skin aging prevention and adult acne. The purpose of this study is to determine the effect of a retinol gummy in adults aged 18-45 on skin aging and overall skin health.

Detailed description: Embody has developed a retinol gummy with the aim to improve the appearance of early signs of aging, such as fine lines, dark spots, and sagging. Embody's retinol gummy has also the goal to reduce the overall frequency of adult acne and an improvement of overall skin health by promoting hydrated, brightened skin. The study aims to collect self-reported outcomes and photographic images to understand the assessment of the efficacy of treatment from the participant's perspective, and if participants see an improvement in their fine lines, wrinkles, dark spots, and sagging.

Eligibility criteria: Inclusion Criteria:

* Male or female between 18-45 years old
* Must be in good general health
* May experiences adult acne and/or early-stage wrinkles that are not treated by topical or oral prescription drugs/medication
* Must maintain a basic skincare routine
* Must discontinue the use of other dietary supplements
* Must be willing to comply with the requirements of the protocol
* Is able to communicate in English
* Is willing to skip their normal skincare routine
* Must provide written informed consent form (ICF)
* Is willing and able to share feedback and take skin pictures via the used technology portal

Exclusion Criteria:

* Unwilling to provide consent
* Unwilling to skip their normal skincare routine
* Unwilling to follow the routine of the protocol
* Use of other oral retinoids
* Use of prescription medication relevant to the skin
* Undergoing any cosmetic procedures during the study including Botox, laser or chemical treatments
* Deep-set of wrinkles
* History of the following medical conditions or diseases:
* Kidney disease
* Liver disease
* Alcohol abuse
* Use of prescription drug (topical or oral) that is targeted at any sort of skin condition (for example retinoids)
* Any known allergies/sensitivities to nuts

Primary outcomes:
measure: Skin aging [Time frame: Baseline to 8 weeks]
timeFrame: 8 week intervention period
measure: Adult acne [Time frame: Baseline to 8 weeks]
timeFrame: 8 week intervention period
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: