A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler … (NCT07204691) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
Sweden75 participantsStarted 2025-09-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 their photographs in publications and the clinical investigation report (CIR). The subject has a right to refuse the photo release without jeopardizing their eligibility to participate in the clinical investigation.
✓. 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 method of contraception for the duration of the clinical investigation (effective birth control measures include sexual abstinence, combined \[estrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal contraception associated with inhibition of ovulation \[oral, injectable, implantable\], intrauterine device \[IUD\] or intrauterine hormone-releasing system \[IUS\] and/or condom with spermicide).
✓. 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.
Exclusion criteria
✕. 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 the subject's ability to participate in the clinical investigation.
What they're measuring
1
Change in Lip Fullness Grading Scale (LFGS) score from baseline to 8 weeks after treatment.
Timeframe: Baseline (prior to treatment) to Week 8
✕. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to the first administration of the investigational device.
✕. Subjects 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 investigation.
✕. 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 effectiveness assessments.