Study to Evaluate Satisfaction After Treatment With Kysse

Galderma R&D59 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lip Augmentation

Interventions

Hyaluronic acidDEVICE

Injectable gel for lip augmentation

Hyaluronic acidDEVICE

Injectable gel. Lip Augmentation and other wrinkles/folds

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Galderma Study Site

Montreal, Canada

Galderma Study Site

Toronto, Canada

Outcomes

Primary Outcomes

Assess Treatment With Restylane Kysse Using GAIS

The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.

Time frame: 8 weeks after last treatment

Data from ClinicalTrials.gov

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