Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 8, 16, 24, 32, 40 and 48
Awards & highlights
Study Summary
This trial will test how well Restylane Kysse works in Chinese subjects to improve the appearance of fine lines and wrinkles.
Who is the study for?
This trial is for adults over 22, of full Chinese descent, who want lip augmentation and can understand English. They must be willing to follow the study rules and not be pregnant or breastfeeding. People with allergies to hyaluronic acid or certain proteins, recent facial procedures, permanent facial treatments, or those in another study within the last month cannot join.Check my eligibility
What is being tested?
The trial is testing Restylane Kysse's ability to enhance lip appearance in an open-label phase IV study. This means everyone knows they're getting this specific lip filler and its effects on aesthetics are being closely monitored post-marketing.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of similar fillers include swelling, redness at injection sites, pain or tenderness in the lips, bruising, itching and possibly lumps or bumps where injected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 or older, not pregnant or breastfeeding, and both my parents are fully Chinese.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 8, 16, 24, 32, 40 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 8, 16, 24, 32, 40 and 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline/last injection on MLFS
Proportion of participants assessed as at least 1-point improvement from baseline on MLFS
Secondary outcome measures
Percentage of participants assessed as at least 1-point improvement from baseline on WAS
Percentage of participants assessed as at least improved on the GAIS
Trial Design
1Treatment groups
Experimental Treatment
Group I: Restylane KysseExperimental Treatment1 Intervention
Hyaluronic Acid
Find a Location
Who is running the clinical trial?
Q-Med ABLead Sponsor
80 Previous Clinical Trials
12,615 Total Patients Enrolled
Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,280 Total Patients Enrolled
Study DirectorStudy DirectorGalderma R&D
1,207 Previous Clinical Trials
489,630 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery, piercings, tattoos, or trauma to my lips or face.I had facial surgery below my eyes less than 6 months ago.I am 22 or older, not pregnant or breastfeeding, and both my parents are fully Chinese.I am allergic to some injectable skin treatments or certain bacterial proteins.I have had permanent or long-lasting facial enhancements below my eyes.I haven't had HA or collagen facial treatments below my eyes in the last year.I am looking to get my lips enhanced.
Research Study Groups:
This trial has the following groups:- Group 1: Restylane Kysse
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently recruiting participants?
"As per information on clinicaltrials.gov, this experiment is now actively recruiting patients for participation; it was first posted in June 13th 2022 and the most recent update occurred August 24th of that year."
Answered by AI
How many participants are taking part in this research?
"Indeed, the particulars on clinicaltrials.gov attest that this trial is actively searching for applicants. The investigation was launched June 13th 2022 with a most recent update of August 24th and requires 50 participants at one medical facility."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger