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

Not Applicable

• Conditions: Elastosis; Atrophy, Hemifacial; Photoaging
• Interventions: Other: Adipeau face cream

• Registration Number: NCT04769193
• Lead Sponsor: Adipeau Inc.

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.

Study Timeline

• Study Start: 2021-01-27
• Status Verified: 2021-02
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-24
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-02
• Primary Completion: 2022-03-27
• Study Completion: 2022-06-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adipeau face cream	Adipeau face cream	Cosmetic cream

Primary Outcome Measures

Name	Time	Method
Change in Skin Elasticity	Six months and 12 months..	Elasticity measured by DermaLab Skin Elasticity Meter.
Change in Skin Volume	Six months and 12 Months.	Increases and decreases measured by Cherry Imaging 3D Scanning System.

Secondary Outcome Measures

Name	Time	Method
FaceQ skin satisfaction surveys	Two, Six and 12 Months.	Satisfaction With Skin, Appraisal of Lower Eyelids, Satisfaction with Cheeks, Adverse Effects

Trial Locations

Locations (1)

Thomas Romo Plastic Surgery; 🇺🇸 New York, New York, United States