Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane … (NCT01428024) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh
Sweden60 participantsStarted 2011-09
Plain-language summary
The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 60 years of age.
* Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip.
* Signed informed consent.
Exclusion Criteria:
* Prior surgery or tattoo to the upper or lower lip or lip line.
* Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry.
* A history of herpes labialis and an outbreak within four weeks of study entry or with four or more outbreaks in the 12 months prior to study entry.
* Presence of facial hair that may interfere with efficacy evaluations.
* Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated.
* History of angioedema.
* Previous hypersensitivity to hyaluronic acid or local anesthetics.
* Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders.
* Cancerous or pre-cancerous lesions in the area to be treated.
* Previous tissue augmenting therapy in the area to be treated with hyaluronic acid (HA) or collagen filler, or laser treatment, during the last 12 months.
* Permanent implant placed in the area to be treated or treatment with non-HA or non-collagen filler in the area to be treated.
* Pregnancy or breast feeding.
* Participation in any other clinical study within 30 days prior to inclusion.
* Other condition preventing the subject to entering the study in the Investigator's opini…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment
Timeframe: At week 8 - change of lips from baseline