New Dermal Filler for Lip Augmentation

NCT ID: NCT03320824

Last Updated: 2022-08-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2019-04-23

Brief Summary

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To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation

Detailed Description

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Conditions

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Lip Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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New Dermal Filler

hyaluronic acid

Group Type EXPERIMENTAL

New Dermal Filler

Intervention Type DEVICE

hyaluronic acid

Dermal Filler

hyaluronic acid

Group Type ACTIVE_COMPARATOR

Device: FDA Approved Dermal Filler

Intervention Type DEVICE

hyaluronic acid

Interventions

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New Dermal Filler

hyaluronic acid

Intervention Type DEVICE

Device: FDA Approved Dermal Filler

hyaluronic acid

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
* Seeking augmentation therapy for the lips

Exclusion Criteria

* Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins.
* Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Testing of Bevelry Hills

Encino, California, United States

Site Status

Cosmetic Laser Dermatology

San Diego, California, United States

Site Status

Art of Skin MD

Solana Beach, California, United States

Site Status

Skin Research Institute, LLC

Coral Gables, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Research Institute of SouthEast

West Palm Beach, Florida, United States

Site Status

Atlanta Dermatology, Vein & Research Center, LLC

Alpharetta, Georgia, United States

Site Status

Maryland Dermatology, Laser, Skin & Vein Institute

Hunt Valley, Maryland, United States

Site Status

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Site Status

BOYD

Birmingham, Michigan, United States

Site Status

Laser & Skin Surgery Center of New York

New York, New York, United States

Site Status

Aesthetic Solutions, PA

Chapel Hill, North Carolina, United States

Site Status

Brian S. Biesman, MD

Nashville, Tennessee, United States

Site Status

Center for Advanced Clinical Research

Dallas, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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43USK1701

Identifier Type: -

Identifier Source: org_study_id

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