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A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity

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ClinicalTrials.gov Identifier: NCT04769193
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
Romo Plastic Surgery
Information provided by (Responsible Party):
Adipeau Inc.

Study Description
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Brief Summary:
A Clinical Trial Evaluating Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers.

Condition or disease Intervention/treatment Phase
Atrophy, Hemifacial Elastosis Photoaging Other: Adipeau face cream Not Applicable

Detailed Description:
This is a single-arm study with subjects serving as their own controls. The study evaluates a face cream comprised of natural agents with adipogenic and lipolytic activities. The combination of adipogenic and lipolytic impulses is theorized to be more effective in promoting regeneration and healthy cell size in the dermal white adipose tissue than other approaches (e.g., adipogenic + lipogenic or anti-adipogenic + lipolytic). The health of the dermal white adipose tissue is reflected by the strength and elasticity of the skin and the distribution of volume in the face.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The evaluation of skin volume will be masked as the assessors will not known which scans are from what time period.
Primary Purpose: Treatment
Official Title: A Clinical Trial Evaluating the Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : March 27, 2022
Estimated Study Completion Date : June 27, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Adipeau face cream
Cosmetic cream
 Other: Adipeau face cream
Adipeau face cream contains the natural actives Carthamus Tinctorius (Safflower) Seed Oil and Kaempferia Parviflora Rhizome Extract (Black Ginger).


Outcome Measures
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Primary Outcome Measures :
  1. Change in Skin Elasticity [ Time Frame: Six months and 12 months.. ]
    Elasticity measured by DermaLab Skin Elasticity Meter.

  2. Change in Skin Volume [ Time Frame: Six months and 12 Months. ]
    Increases and decreases measured by Cherry Imaging 3D Scanning System.


Secondary Outcome Measures :
  1. FaceQ skin satisfaction surveys [ Time Frame: Two, Six and 12 Months. ]
    Satisfaction With Skin, Appraisal of Lower Eyelids, Satisfaction with Cheeks, Adverse Effects


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • Plans to undergo facial skin resurfacing (e.g. laser, chemical peel, microneedling) during the study period
  • Plans to undergo injectable filler treatment.
Contacts and Locations
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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): NCT04769193


Contacts
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Contact: Jacob Tower, MD 646-694-0991 care@adipeau.com

Locations
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United States, New York
Thomas Romo Plastic Surgery Recruiting
New York, New York, United States, 10021
Contact: Thomas Romo, MD    212-288-1500    dr.romo@romoplasticsurgery.com   
Sponsors and Collaborators
Adipeau Inc.
Romo Plastic Surgery
Investigators
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Principal Investigator: Jacob Tower, MD Romo Plastic Surgery
More Information
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Publications:

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Responsible Party: Adipeau Inc.
ClinicalTrials.gov Identifier: NCT04769193    
Other Study ID Numbers: Adipeau-001
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 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 Adipeau Inc.:
Sagging
Depletion
Atrophy
Photoaging
Additional relevant MeSH terms:
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Facial Hemiatrophy
Atrophy
Pathological Conditions, Anatomical
Mouth Diseases
 Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases