CompletedNot Applicable

Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of NLF Appearance

Sweden48 participantsStarted 2021-08-20

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 23 versus Juvederm Volift™ after injection into the mid to deep dermis for correction of moderate to deep nasolabial folds (NLFs).

Who can participate

Age range18 Years – 65 Years

SexALL

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 subjects aged 18 to 65 years (inclusive) at the time of screening.
✓. Subject desires correction of NLFs.
✓. Moderate to severe bilateral aging defects in the nasolabial area, with wrinkles classified as grade 3 or 4 according to the NLF WSRS on each side as assessed by the blinded evaluator. NLFs should be of the same grade on the left and right side of the face (i.e. approximate bilateral symmetry).
✓. Subject, that in the opinion of the blinded evaluator, can improve at least 1 step on the investigator-rated NLF WSRS with a maximum volume of 2.0 mL/NLF for initial treatment and 1.0 mL/NLF for touch-up.
✓. 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).
✓. 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.

What they're measuring

Comparison of the rate of responders determined by the aesthetic improvement of the NLFs according to live on-site evaluator-rated NLF WSRS at 6 months post-treatment between the investigational device and comparator product.

Timeframe: Baseline (pre-treatment) to 6 months post-treatment

Trial details

NCT IDNCT05021913

SponsorDr. Korman Laboratories Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-06

View on ClinicalTrials.gov More Aging, Premature trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

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 subjects aged 18 to 65 years (inclusive) at the time of screening.
✓. Subject desires correction of NLFs.
✓. Moderate to severe bilateral aging defects in the nasolabial area, with wrinkles classified as grade 3 or 4 according to the NLF WSRS on each side as assessed by the blinded evaluator. NLFs should be of the same grade on the left and right side of the face (i.e. approximate bilateral symmetry).
✓. Subject, that in the opinion of the blinded evaluator, can improve at least 1 step on the investigator-rated NLF WSRS with a maximum volume of 2.0 mL/NLF for initial treatment and 1.0 mL/NLF for touch-up.
✓. 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).
✓. 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.

Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of NLF Appearance

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of NLF Appearance

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria