Back to resultsA Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity
Primary Purpose
Atrophy, Hemifacial, Elastosis, Photoaging
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adipeau face cream
Sponsored by
About this trial
This is an interventional treatment trial for Atrophy, Hemifacial focused on measuring Sagging, Depletion, Atrophy, Photoaging
Eligibility 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.
Sites / Locations
- Thomas Romo Plastic SurgeryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adipeau face cream
Arm Description
Cosmetic cream
Outcomes
Primary Outcome Measures
Change in Skin Elasticity
Elasticity measured by DermaLab Skin Elasticity Meter.
Change in Skin Volume
Increases and decreases measured by Cherry Imaging 3D Scanning System.
Secondary Outcome Measures
FaceQ skin satisfaction surveys
Satisfaction With Skin, Appraisal of Lower Eyelids, Satisfaction with Cheeks, Adverse Effects
Full Information
NCT ID
NCT04769193
First Posted
February 22, 2021
Last Updated
February 26, 2021
Sponsor
Adipeau Inc.
Collaborators
Romo Plastic Surgery
1. Study Identification
Unique Protocol Identification Number
NCT04769193
Brief Title
A Clinical Trial Evaluating the Efficacy of a Skin Cream in Improving Facial Appearance and Skin Elasticity
Official Title
A Clinical Trial Evaluating the Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
March 27, 2022 (Anticipated)
Study Completion Date
June 27, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adipeau Inc.
Collaborators
Romo Plastic Surgery
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Clinical Trial Evaluating Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophy, Hemifacial, Elastosis, Photoaging
Keywords
Sagging, Depletion, Atrophy, Photoaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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.
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adipeau face cream
Arm Type
Experimental
Arm Description
Cosmetic cream
Intervention Type
Other
Intervention Name(s)
Adipeau face cream
Intervention Description
Adipeau face cream contains the natural actives Carthamus Tinctorius (Safflower) Seed Oil and Kaempferia Parviflora Rhizome Extract (Black Ginger).
Primary Outcome Measure Information:
Title
Change in Skin Elasticity
Description
Elasticity measured by DermaLab Skin Elasticity Meter.
Time Frame
Six months and 12 months..
Title
Change in Skin Volume
Description
Increases and decreases measured by Cherry Imaging 3D Scanning System.
Time Frame
Six months and 12 Months.
Secondary Outcome Measure Information:
Title
FaceQ skin satisfaction surveys
Description
Satisfaction With Skin, Appraisal of Lower Eyelids, Satisfaction with Cheeks, Adverse Effects
Time Frame
Two, Six and 12 Months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Tower, MD
Phone
646-694-0991
Email
care@adipeau.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Tower, MD
Organizational Affiliation
Romo Plastic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Romo Plastic Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Romo, MD
Phone
212-288-1500
Email
dr.romo@romoplasticsurgery.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32914326
Citation
Galanin I, Nicu C, Tower JI. Facial Fat Fitness: A New Paradigm to Understand Facial Aging and Aesthetics. Aesthetic Plast Surg. 2021 Feb;45(1):151-163. doi: 10.1007/s00266-020-01933-6. Epub 2020 Sep 10.
Results Reference
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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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