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NCT03967444 Clinical Trial

Study to Evaluate Satisfaction After Treatment With Kysse

Lip Augmentation Clinical Trial

Official title:
Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03967444
Other study ID # 05DF1807
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date September 18, 2019

Study information
Verified date February 2021
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date September 18, 2019
Est. primary completion date September 18, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Hyaluronic acid
Injectable gel for lip augmentation
• Hyaluronic acid
Injectable gel. Lip Augmentation and other wrinkles/folds

Locations
Country Name City State
Canada Galderma Study Site Montréal
Canada Galderma Study Site Toronto

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 8 weeks after last treatment
See also
  Status Clinical Trial Phase
Completed NCT04540913 - RHA® 3 Versus Restylane-L® for Lip Augmentation
Completed NCT03320824 - New Dermal Filler for Lip Augmentation N/A
Completed NCT05730543 - Ethnic Lip Augmentation With Hyaluronic Acid Filler Phase 3
Completed NCT04839692 - Assessment and Augmentation of Lip Appearance in Specific Study Populations Phase 4
Terminated NCT04299295 - To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area. N/A
Completed NCT01629134 - Postmarket Study of JUVÉDERM VOLBELLA™ With Lidocaine in the Lips N/A
Terminated NCT04029545 - A Multicenter, Double-blind, Randomized, Controlled, Roll-over Retreatment Study of the Safety and Pain Associated With Injections of PN40082, RV001 With Topical Anesthetic or RV001 for Lip Augmentation Phase 3
Active, not recruiting NCT05342753 - Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects N/A
Completed NCT00935272 - Safety/Efficacy Study of Restylane® in Lip Augmentation N/A
Recruiting NCT05314504 - Clinical Investigation of YVOIRE Y-Solution 360 for Lip Augmentation in China N/A
Completed NCT04029519 - A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation Phase 3
Completed NCT03796728 - A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation Phase 4
Completed NCT01197495 - Safety and Effectiveness of Juvederm(R) Ultra XC Injectable Gel for Lip Augmentation N/A