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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04884516
Recruitment Status : Completed
First Posted : May 13, 2021
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
Citruslabs
Information provided by (Responsible Party):
Embody Beauty, Inc.

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.

Condition or disease Intervention/treatment Phase
Acne, Adult Dietary Supplement: Retinol gummy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : January 19, 2021
Actual Primary Completion Date : April 15, 2021
Actual Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention arm
Participants take retinol gummy once a day
Dietary Supplement: Retinol gummy
Participants take one retinol gummy per day




Primary Outcome Measures :
  1. 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

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884516


Locations
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United States, California
Citruslabs
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Embody Beauty, Inc.
Citruslabs
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Responsible Party: Embody Beauty, Inc.
ClinicalTrials.gov Identifier: NCT04884516    
Other Study ID Numbers: EmbodyRetinol
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Embody Beauty, Inc.:
skin aging
adult acne
Additional relevant MeSH terms:
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Vitamin A
Vitamins
Micronutrients
Physiological Effects of Drugs