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

NCT ID: NCT04769193

Last Updated: 2021-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2022-06-27

Brief Summary

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

Detailed Description

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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.

Conditions

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Atrophy, Hemifacial Elastosis Photoaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The evaluation of skin volume will be masked as the assessors will not known which scans are from what time period.

Study Groups

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Adipeau face cream

Cosmetic cream

Group Type EXPERIMENTAL

Adipeau face cream

Intervention Type OTHER

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

Interventions

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Adipeau face cream

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Romo Plastic Surgery

UNKNOWN

Sponsor Role collaborator

Adipeau Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob Tower, MD

Role: PRINCIPAL_INVESTIGATOR

Romo Plastic Surgery

Locations

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Thomas Romo Plastic Surgery

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jacob Tower, MD

Role: CONTACT

646-694-0991

Facility Contacts

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Thomas Romo, MD

Role: primary

212-288-1500

References

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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.

Reference Type BACKGROUND
PMID: 32914326 (View on PubMed)

Other Identifiers

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Adipeau-001

Identifier Type: -

Identifier Source: org_study_id

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