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

May 11, 2021 updated by: Embody Beauty, Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention arm
Participants take retinol gummy once a day
Dietary supplement: Retinol gummy
Participants take one retinol gummy per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 week intervention period
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)
8 week intervention period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Embody Beauty, Inc.

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

April 15, 2021

Study Registration Dates

First Submitted

May 6, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 13, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EmbodyRetinol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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