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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 15, 2021

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.

Interventions

  • Dietary Supplement: Retinol gummy
    • Participants take one retinol gummy per day

Arms, Groups and Cohorts

  • Other: Intervention arm
    • Participants take retinol gummy once a day

Clinical Trial Outcome Measures

Primary Measures

  • Skin aging [Time frame: Baseline to 8 weeks]
    • Time Frame: 8 week intervention period
    • 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
  • Adult acne [Time frame: Baseline to 8 weeks]
    • Time Frame: 8 week intervention period
    • Reduction the overall frequency and intensity of adult acne (Scale 0-5 with higher scores representing a reduction in the appearance of adult acne)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Embody Beauty, Inc.
  • Collaborator
    • Citruslabs
  • Provider of Information About this Clinical Study
    • Sponsor

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