NCT04769193

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2021

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2022

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

February 22, 2021

Last Update Submit

February 26, 2021

Conditions

Atrophy, HemifacialElastosisPhotoaging

Keywords

SaggingDepletionAtrophyPhotoaging

Outcome Measures

Primary Outcomes (2)

  • Change in Skin Elasticity

    Elasticity measured by DermaLab Skin Elasticity Meter.

    Six months and 12 months..

  • Change in Skin Volume

    Increases and decreases measured by Cherry Imaging 3D Scanning System.

    Six months and 12 Months.

Secondary Outcomes (1)

  • FaceQ skin satisfaction surveys

    Two, Six and 12 Months.

Study Arms (1)

Adipeau face cream

EXPERIMENTAL

Cosmetic cream

Other: Adipeau face cream

Interventions

Adipeau face creamOTHER

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

Adipeau face cream

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Plans to undergo facial skin resurfacing (e.g. laser, chemical peel, microneedling) during the study period
  • Plans to undergo injectable filler treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Romo Plastic Surgery

New York, New York, 10021, United States

RECRUITING

Related 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.

    PMID: 32914326BACKGROUND

MeSH Terms

Conditions

Facial HemiatrophyAtrophy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jacob Tower, MD

    Romo Plastic Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob Tower, MD

CONTACT

646-694-0991care@adipeau.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The evaluation of skin volume will be masked as the assessors will not known which scans are from what time period.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 24, 2021

Study Start

January 27, 2021

Primary Completion

March 27, 2022

Study Completion

June 27, 2022

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)