Study To Investigate If Embody's Retinol Gummies Improve The Early Signs Of Skin Aging And Overall Skin Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Acne, Adult

Intervention / Treatment
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* Dietary Supplement: Retinol gummy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention arm<br>Participants take retinol gummy once a day | Dietary Supplement: Retinol gummy<br>* Participants take one retinol gummy per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin aging [Time frame: Baseline to 8 weeks] | Patient reported outcome measures (Scale 0-5 with higher scores representing a better outcome) to assess the reduction of early signs of aging such as fine lines, dark spots, and sagging | 8 week intervention period | 
| Adult acne [Time frame: Baseline to 8 weeks] | Reduction the overall frequency and intensity of adult acne (Scale 0-5 with higher scores representing a reduction in the appearance of adult acne) | 8 week intervention period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin aging, adult acne