Study to Evaluate Satisfaction After Treatment With Kysse

NCT ID: NCT03967444

Last Updated: 2022-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2019-09-18

Brief Summary

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Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.

Detailed Description

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Conditions

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Lip Augmentation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Restylane Kysse

Hyaluronic acid

Group Type OTHER

Hyaluronic acid

Intervention Type DEVICE

Injectable gel for lip augmentation

Restylane Kysse with other HA

Hyaluronic acid

Group Type OTHER

Hyaluronic acid

Intervention Type DEVICE

Injectable gel. Lip Augmentation and other wrinkles/folds

Interventions

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Hyaluronic acid

Injectable gel for lip augmentation

Intervention Type DEVICE

Hyaluronic acid

Injectable gel. Lip Augmentation and other wrinkles/folds

Intervention Type DEVICE

Other Intervention Names

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Restylane Kysse Restylane Kysse with other Restylane products

Eligibility Criteria

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Inclusion Criteria

* Signed and dated informed consent to participate in the study
* Adult women and men who intend to undergo lip augmentation

Exclusion Criteria

* Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
* Subjects with a previous implant other than HA in or near the intended treatment site
* Participation in any other clinical study within three (3) months before treatment
Minimum Eligible Age

18 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

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Galderma Study Site

Montreal, , Canada

Site Status

Galderma Study Site

Toronto, , Canada

Site Status

Countries

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Canada

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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05DF1807

Identifier Type: -

Identifier Source: org_study_id

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