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Tests treatment safety and results for Lip Augmentation
Official title A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
ClinicalTrials.gov ID: NCT07204691
What this study is testing
- What it's testing
- This study will assess the safety and effectiveness of a dermal filler called DKL crosslinked hyaluronic acid 20 mg/mL with lidocaine 0.3% when injected into the lips of healthy men and women who want to have fuller lips. The change in the appearance of the lips will be checked.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Review and sign the IEC-approved Informed Consent Form (ICF) prior to any clinical investigation-related procedures being performed. In addition, the...
- Healthy male or female subject aged 18 inclusive, at the time of screening.
- Has both an upper and lower lip that are very thin, or thin on the LFGS, and desires at least a 1-point improvement in LFGS score in either lip.
- Female of childbearing potential (sexually active and not sterile nor postmenopausal for at least 1 year) should have a urine pregnancy test...
- The subject has an adequate understanding of the local language to understand verbal and written subject information and is willing to comply with...
You likely can't join if
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of...
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of the investigational...
- people with epilepsy.
- History of streptococcal disease (such as recurrent sore throats), rheumatic fever or acute rheumatic fever.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snus/nicotine pouches, snuffing, chewing tobacco) less than...
- Known hypersensitivity to HA and/or to gram-positive bacterial proteins, as HA.
See the full eligibility criteria
Who can join
- Review and sign the IEC-approved Informed Consent Form (ICF) prior to any clinical investigation-related procedures being performed. In addition, the subject will be asked to provide a separate release for the use of...
- Healthy male or female subject aged 18 inclusive, at the time of screening.
- Has both an upper and lower lip that are very thin, or thin on the LFGS, and desires at least a 1-point improvement in LFGS score in either lip.
- Female of childbearing potential (sexually active and not sterile nor postmenopausal for at least 1 year) should have a urine pregnancy test evaluated as negative on the day of enrollment and agree to use a reliable...
- The subject has an adequate understanding of the local language to understand verbal and written subject information and is willing to comply with the clinical investigation requirements.
What rules you out
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the clinical investigation or influence the results or...
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of the investigational device.
- people with epilepsy.
- History of streptococcal disease (such as recurrent sore throats), rheumatic fever or acute rheumatic fever.
- Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snus/nicotine pouches, snuffing, chewing tobacco) less than 3 times/week before the screening visit is allowed.
- Known hypersensitivity to HA and/or to gram-positive bacterial proteins, as HA.
- History of allergy, anaphylaxis, or hypersensitivity to injectable HA products, local anesthetics of the amide-type such as lidocaine, or latex, or is planning to undergo desensitization therapy during the clinical...
- Has lip tattoos, piercings, facial hair, tissue damage/malformation in the mouth (e.g., due to snus/nicotine pouch use) or scars that would interfere with visualization of the lips and perioral area for the how well it...
- Has abnormal lip function, with an inability to effectively sip water through a straw.
- Has abnormal lip sensation, with an inability to feel a 0.4G monofilament or a cotton wisp at any site on the lip.
- Has moderate or severe abnormal lip asymmetry.
- Has any mass-formation on the lip.
- Has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities as judged by the Treating Investigator. people planning to undergo extensive...
- Has used ANY lip filling agents within 12 months of clinical investigation enrollment (HA products, collagen-based products, etc.).
- Has used permanent and/or semi-permanent lip filling agents (e.g., silicone, collagen, calcium).
- Has used any lip-plumping products or devices within 10 days before enrollment or is planning to use such products during the clinical investigation.
- Has begun using any over-the-counter (OTC) or prescription oral or topical anti-wrinkle products for the lips or around the mouth within 90 days before enrollment or is planning to begin using such products during the...
- Is on an ongoing regimen of anti-coagulation therapy (e.g., warfarin), thrombolytics, or inhibitors of platelet aggregation or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen) or other substances...
- Has a history or presence of bleeding disorders.
- Has used systemic corticosteroids or immunosuppressive medications within 30 days prior to treatment.
- Is on a concurrent regimen of lidocaine or structurally related local anesthetics (e.g., bupivacaine).
- Has an active inflammation (skin eruptions such as cysts, pimples, rashes, or hives), infection, cancerous or pre-cancerous lesion, or unhealed wound on the face.
- Has a history of known susceptibility to keloid formation or hypertrophic scars.
- Has active herpes labialis lesions at the time of injections. people with a history of herpes labialis who have had four or more outbreaks in the 12 months prior to enrollment are also excluded even in the absence of...
- people who are pregnant, lactating, or planning to become pregnant at any time during the clinical investigation.
- History of alcohol or drug abuse or excessive intake of alcohol, as judged by the Investigator.
- Has received any investigational device within 30 days prior to clinical investigation enrollment or is planning to participate in another investigation during the course of this clinical investigation.
- Is an employee (or a relative of an employee) of the Monitor or contract research organization (CRO) responsible for conducting the clinical investigation, the Sponsor, or a Sponsor representative.
- The Investigator considers the subject unlikely to comply with clinical investigation procedures, restrictions, and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Mölndal, Sweden
- Solna, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mölndal, Sweden; Solna, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.