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

February 26, 2021 updated by: Adipeau Inc.

A Clinical Trial Evaluating the Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers

A Clinical Trial Evaluating Efficacy of a Skin Cream Targeting Dermal Fat in Improving the Skin Elasticity of Healthy Volunteers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

75

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 Contact

Study Locations

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Skin Elasticity
Time Frame: Six months and 12 months..
Elasticity measured by DermaLab Skin Elasticity Meter.
Six months and 12 months..
Change in Skin Volume
Time Frame: Six months and 12 Months.
Increases and decreases measured by Cherry Imaging 3D Scanning System.
Six months and 12 Months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FaceQ skin satisfaction surveys
Time Frame: Two, Six and 12 Months.
Satisfaction With Skin, Appraisal of Lower Eyelids, Satisfaction with Cheeks, Adverse Effects
Two, Six and 12 Months.

Collaborators and Investigators

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

Sponsor

Adipeau Inc.

Collaborators

Romo Plastic Surgery

Investigators

  • Principal Investigator: Jacob Tower, MD, Romo Plastic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 27, 2021

Primary Completion (Anticipated)

March 27, 2022

Study Completion (Anticipated)

June 27, 2022

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adipeau-001

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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