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NCT04769193 Clinical Trial

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

Photoaging Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04769193
Other study ID # Adipeau-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 27, 2021
Est. completion date June 27, 2022

Study information
Verified date February 2021
Source Adipeau Inc.
Contact Jacob Tower, MD
Phone 646-694-0991
Email care@adipeau.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 75
Est. completion date June 27, 2022
Est. primary completion date March 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Adipeau face cream
Adipeau face cream contains the natural actives Carthamus Tinctorius (Safflower) Seed Oil and Kaempferia Parviflora Rhizome Extract (Black Ginger).

Locations
Country Name City State
United States Thomas Romo Plastic Surgery New York New York

Sponsors (2)
Lead Sponsor Collaborator
Adipeau Inc. Romo Plastic Surgery

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Skin Elasticity Elasticity measured by DermaLab Skin Elasticity Meter. Six months and 12 months..
Primary Change in Skin Volume Increases and decreases measured by Cherry Imaging 3D Scanning System. Six months and 12 Months.
Secondary FaceQ skin satisfaction surveys Satisfaction With Skin, Appraisal of Lower Eyelids, Satisfaction with Cheeks, Adverse Effects Two, Six and 12 Months.
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