Safety and Performance of DKL Crosslinked Sodium Hyaluronate 26 Dermal Filler for Cheek Augmentation (NCT05021926) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance of DKL Crosslinked Sodium Hyaluronate 26 Dermal Filler for Cheek Augmentation
Sweden48 participantsStarted 2021-08-30
Plain-language summary
This is a pivotal, prospective, active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison, non-inferiority study of DKL crosslinked sodium hyaluronate 26 versus Juvederm Voluma™ after treatment of subcutaneous to upper-periostea tissue, or deep dermis implantation for cheek augmentation and age-related facial-volume deficit.
Who can participate
Age range
18 Years – 65 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
. Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed. In addition, the subject will be asked to provide a separate release for 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 study.
. Male and female subject aged 18 to 65 years (inclusive) at the time of screening.
. The subject desires cheek augmentation and/or correction of age-related midface contour deficiencies.
. Midface with a MMVS score of 3 (moderate loss of fullness with slight hollowing below malar prominence) or 4 (substantial loss of fullness in the midface area, clearly apparent hollowing below malar prominence) on each side of the face as assessed by the blinded evaluator. Both sides of the face should have the same scoring.
. Female of child-bearing 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 enrolment, and agree to use a reliable method of contraception for the duration of the study (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).
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
Comparison of the rate of responders determined by the aesthetic improvement of the midface according to live on-site evaluator-rated MMVS at 6 months post-treatment between the investigational device and comparator product.
Timeframe: Baseline (pre-treatment) to 6 months post-treatment
. Subject agrees to abstain from any facial cosmetic or surgical procedures during the study period.
. Subject agrees to refrain from excessive weight gain or loss (±10%) during the investigation period.
. Subject has adequate understanding of the local language to understand verbal and written subject information and is willing to comply with the study requirements.
Exclusion criteria
. History of any clinically significant disease or disorder, including porphyria or systemic disorders affecting wound healing, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
. Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational device and comparator.
. History of anaphylaxis, multiple severe allergies, atopy, or allergy to sodium hyaluronate products or to streptococcal proteins or have plans to undergo desensitization therapy during the term of the study.
. History of immune system disorders (e.g., autoimmune disease, human immunodeficiency virus \[HIV\]-positive status, history of immune system degradation, or recurrent herpes simplex).
. History of streptococcal disease (e.g. recurrent sore throat) and subjects with rheumatic fever, as judged by the investigator.
. Dermatological problems (e.g. cutaneous lesions, inflammatory skin conditions, hypertrophic scars or a tendency for keloid formation) at the discretion of the investigator.
. Noticeable scarring (including acne scarring), prior surgery, an active inflammation, infection, cancerous or pre-cancerous lesion, history of prior significant trauma to the midface, such as dog bite or laceration, resulting in formation of a scar, or unhealed wound or have undergone radiation treatment in the area to be treated.
. Cheek tattoos, piercings, facial hair, or scars that would interfere with visualization of the cheek area for the effectiveness assessments.