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

Sponsor

Adipeau Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04769193

Collaborator

Romo Plastic Surgery (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jan 27, 2021

Anticipated Primary Completion Date :

Mar 27, 2022

Anticipated Study Completion Date :

Jun 27, 2022

Arms and Interventions

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).

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

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.