Aging, PrematureNCT05021913
Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of NLF Appearance
A study testing DKL crosslinked sodium hyaluronate 23 and Juvéderm Volift™ with lidocaine (Allergan, Inc) in people with Aging, Premature, run by Dr. Korman Laboratories Ltd. at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Premature
- What is being tested?
- DKL crosslinked sodium hyaluronate 23 and Juvéderm Volift™ with lidocaine (Allergan, Inc)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 20 Aug 2021to 6 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Very thin skin in the mid-facial region, tendency to accumulate fluid in the lower eyelids, or large infraorbital fat pads, i.e., significant convexity or projection from the infraorbital fat pads.
- Mid-face volume deficit due to congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease or HIV-related disease.
- Moderate or severe abnormal midface or cheek asymmetry.
- Ongoing or history of use of immunosuppressive therapy.
- Use of anti-coagulation, anti-platelet, or thrombolytic medications, anti-inflammatory drugs, or other substances known to increase coagulation time (as detailed in Section 9.6.2) within 10 days prior to treatment with the investigational device and comparator.
- Use of any new (i.e. that the subject has not used before) facial over-the-counter or prescription, oral or topical, anti-wrinkle products within 90 days prior to enrolment or planning to begin use of such products at any time during the study.
- NOTE: Continued therapy with some cosmeceuticals (e.g., alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids) is allowed if the regimen was established ≥ 90 days prior to enrolment. The use of sunscreens is also allowed.
- Known sensitivity to any investigational device or comparator components (see Section 10.1).
- Previous cosmetic or aesthetic procedures as follows:
- All types of previous surgical surgery below the lower orbital rim ii) All types of permanent fillers below the lower orbital rim iii) Previous semi-permanent fillers below the orbital less than 2 years before treatment iv) Previous treatment with HA-based fillers less the 18 months prior to enrolment v) Treatment with photochemotherapy or lasers less than 6 months before enrolment vi) Mechanical, chemical or medical peeling less than 6 months prior to enrolment vii) Treatment with botulinum toxins less than 12 months prior to enrollment viii) Major dental procedures less than 6 months prior to enrolment
- The presence of abnormal midface function, with inability to effectively puff cheeks, smile broadly, or chew.
- Pregnant, lactating, or planning to become pregnant at any time during the study.
- Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the investigational device and comparator.
- 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 study enrolment or is planning to participate in another investigation during the course of this study.
- No access to an electronic device (e.g. smartphone, tablet or personal computer) on which to complete eDiaries.
- Is an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, sponsor, or a sponsor representative.
- The Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of Nasolabial Fold Appearance
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).
Read the detailed description
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).
Approximately 40 subjects will be randomized and treated. Subjects will come to the research clinic for up to 6 visits, including a screening/baseline visit and up to 5 follow-up visits.
At Screening eligible subjects (males and females aged 18 to 65 years) will be randomized as to which NLF will be treated with the investigational device and which NLF will be treated with the comparator device.
The subjects will undergo baseline assessments of NLF Wrinkle Severity Rating Scale (WSRS) by the evaluating investigator and have baseline two-dimensional (2D) photos taken, prior to treatment with the investigational device and comparator.
Treatment will be performed by an unblinded treating investigator. Following treatment, the subjects will complete a subject eDiary in which they will assess pre-defined treatment related events experienced during the first 14 days after the injection.
Additional visits will take place 1, 3, 6 and 9 months after the treatment. During these visits the subjects will undergo evaluations by an evaluating investigator blinded to the treatment allocation. Assessments will include photography, NLF WSRS and Global Aesthetic Improvement Scale (GAIS). The subjects will also evaluate treatment outcome using the GAIS and complete a patient satisfaction questionnaire. The investigator will record any adverse events (AEs) that have occurred and will note their severity and relationship to the injected product.
An optional touch-up treatment will be performed one month after the initial treatment at the discretion of the treating investigator. Subjects requiring touch-up will receive touch-up according to the original randomization scheme, i.e. the investigational device and comparator product will be injected to the same NLF according to the randomization scheme. Following touch-up, these subjects will be asked to complete a subject eDiary for assessment of pre-defined treatment related events experienced during the first 14 days after the injection. Subjects receiving touch-up will attend and additional evaluation visit one month after touch-up (in addition to other visits).
The treating investigators will complete a usability questionnaire.
- Conditions
- Aging, Premature
- Being tested
- DKL crosslinked sodium hyaluronate 23, Juvéderm Volift™ with lidocaine (Allergan, Inc)
- Keywords
- Premature skin aging, Correction of facial structural defects, Wrinkles
- Medical subject headings
- Aging, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKL crosslinked sodium hyaluronate 23Device
is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 23 will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
Juvéderm Volift™ with lidocaine (Allergan, Inc)Device
is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Volift™ will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device | Experimental | DKL crosslinked sodium hyaluronate 23 Receives: Device: DKL crosslinked sodium hyaluronate 23 |
| Comparator product | Active comparator | Juvéderm Volift™ with lidocaine (Allergan, Inc) Receives: Device: Juvéderm Volift™ with lidocaine (Allergan, Inc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The NLF WSRS is a 5-point scale ranging from 1 (No visible fold; continuous skin line) to 5 (Extremely deep and long folds; detrimental to facial appearance; 2- to 4-mm visible V-shaped fold when stretched). Response is defined as ≥ 1-point improvement on the NLF WSRS for each NLF compared to baseline. Each NLF is to be assessed separately.
Measured: Baseline (pre-treatment) to 6 months post-treatment
Secondary outcomes (8)
Comparison of the rate of responders determined by the aesthetic improvement of the NLFs according to live on-site evaluator-rated NLF WSRS at 1, 3 and 9 months post-treatment between the investigational device and comparator product.
The NLF WSRS is a 5-point scale ranging from 1 (No visible fold; continuous skin line) to 5 (Extremely deep and long folds; detrimental to facial appearance; 2- to 4-mm visible V-shaped fold when stretched). Response is defined as ≥ 1-point improvement on the NLF WSRS for each NLF compared to baseline. Each NLF is to be assessed separately.
Measured: Baseline (pre-treatment) to 1, 3 and 9 months post-treatment
Comparison of the mean change in evaluator-rated NLF WSRS from baseline (pre-treatment) to at 1, 3, 6 and 9 months post-treatment between the investigational device and comparator product.
The NLF WSRS is a 5-point scale ranging from 1 (No visible fold; continuous skin line) to 5 (Extremely deep and long folds; detrimental to facial appearance; 2- to 4-mm visible V-shaped fold when stretched).
Measured: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Subject-rated aesthetic improvement in appearance according to GAIS at 1, 3, 6 and 9 months post-treatment. Each NLF is to be assessed separately.
The 5-grade GAIS assesses the appearance of the NLF compared to pre-treatment on a scale ranging from very much improved to worse.
Measured: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Evaluating Investigator-rated aesthetic improvement in appearance according to the GAIS at 1, 3, 6 and 9 months post-treatment. Each NLF is to be assessed separately.
The 5-grade GAIS assesses the appearance of the NLF compared to pre-treatment on a scale ranging from very much improved to worse.
Measured: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Usability of the device
Investigator-reported usability of the device. A device usability questionnaire will be completed once by each treating investigator after treatment of his/her last subject.
Measured: Baseline - treatment
Subject-reported satisfaction with treatment as assessed by a subject satisfaction questionnaire at 1, 3, 6 and 9 months post-treatment.
Satisfaction will be assessed on a 5-point scale ranging from very satisfied (1) to very dissatisfied (5).
Measured: 1, 3, 6 and 9 months post-treatment
Post-treatment events
Incidence, intensity, and duration of pre-defined expected post-treatment events collected using a subject electronic diary (eDiary) for 14 days post treatment.
Measured: Up to 14 days post-treatment
Adverse Events
Frequency, intensity and seriousness of adverse events (AEs).
Measured: Up to 9 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start20 Aug 2021
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging, PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pivotal, prospective, active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Korman Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Johan Nilsson, MD, PhD, Principal investigator, CTC Clinical Trial Consultants ABMohammad Alimohammadi, MD, PhD, Principal investigator, Almo Alo AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021913
- Sponsor's protocol ID
- VAL-P68
- Status last verified
- Jul 2023
- First submitted
- 19 Aug 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Performance of DKL Crosslinked Sodium Hyaluronate 23 Dermal Filler for Improvement of Nasolabial Fold Appearance
- ClinicalTrials.gov ID
- NCT05021913
- Acronym / sponsor ID
- VAL-P68
- Conditions
- Aging, Premature
- Keywords
- Premature skin aging, Correction of facial structural defects, Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Dr. Korman Laboratories Ltd.Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Approximately 40 subjects will be randomized and treated. Subjects will come to the research clinic for up to 6 visits, including a screening/baseline visit and up to 5 follow-up visits.
At Screening eligible subjects (males and females aged 18 to 65 years) will be randomized as to which NLF will be treated with the investigational device and which NLF will be treated with the comparator device.
The subjects will undergo baseline assessments of NLF Wrinkle Severity Rating Scale (WSRS) by the evaluating investigator and have baseline two-dimensional (2D) photos taken, prior to treatment with the investigational device and comparator.
Treatment will be performed by an unblinded treating investigator. Following treatment, the subjects will complete a subject eDiary in which they will assess pre-defined treatment related events experienced during the first 14 days after the injection.
Additional visits will take place 1, 3, 6 and 9 months after the treatment. During these visits the subjects will undergo evaluations by an evaluating investigator blinded to the treatment allocation. Assessments will include photography, NLF WSRS and Global Aesthetic Improvement Scale (GAIS). The subjects will also evaluate treatment outcome using the GAIS and complete a patient satisfaction questionnaire. The investigator will record any adverse events (AEs) that have occurred and will note their severity and relationship to the injected product.
An optional touch-up treatment will be performed one month after the initial treatment at the discretion of the treating investigator. Subjects requiring touch-up will receive touch-up according to the original randomization scheme, i.e. the investigational device and comparator product will be injected to the same NLF according to the randomization scheme. Following touch-up, these subjects will be asked to complete a subject eDiary for assessment of pre-defined treatment related events experienced during the first 14 days after the injection. Subjects receiving touch-up will attend and additional evaluation visit one month after touch-up (in addition to other visits).
The treating investigators will complete a usability questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Pivotal, prospective, active-controlled, randomized, double blinded (blinded evaluator and subject), intra-individual split-face comparison
| Arm | Type | Receives |
|---|---|---|
| Investigational device | Experimental | Device: DKL crosslinked sodium hyaluronate 23DKL crosslinked sodium hyaluronate 23 |
| Comparator product | Active comparator | Device: Juvéderm Volift™ with lidocaine (Allergan, Inc)Juvéderm Volift™ with lidocaine (Allergan, Inc) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DKL crosslinked sodium hyaluronate 23is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 23 will be injected on Day 30; the volume of injection will not exceed 1 mL per side. | Device | Investigational device |
| Juvéderm Volift™ with lidocaine (Allergan, Inc)is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Volift™ will be injected on Day 30; the volume of injection will not exceed 1 mL per side. | Device | Comparator product |
Primary outcome
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.
Time frame: Baseline (pre-treatment) to 6 months post-treatment
The NLF WSRS is a 5-point scale ranging from 1 (No visible fold; continuous skin line) to 5 (Extremely deep and long folds; detrimental to facial appearance; 2- to 4-mm visible V-shaped fold when stretched). Response is defined as ≥ 1-point improvement on the NLF WSRS for each NLF compared to baseline. Each NLF is to be assessed separately.
8 secondary outcomes
Comparison of the rate of responders determined by the aesthetic improvement of the NLFs according to live on-site evaluator-rated NLF WSRS at 1, 3 and 9 months post-treatment between the investigational device and comparator product.
Time frame: Baseline (pre-treatment) to 1, 3 and 9 months post-treatment
Comparison of the mean change in evaluator-rated NLF WSRS from baseline (pre-treatment) to at 1, 3, 6 and 9 months post-treatment between the investigational device and comparator product.
Time frame: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Subject-rated aesthetic improvement in appearance according to GAIS at 1, 3, 6 and 9 months post-treatment. Each NLF is to be assessed separately.
Time frame: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Evaluating Investigator-rated aesthetic improvement in appearance according to the GAIS at 1, 3, 6 and 9 months post-treatment. Each NLF is to be assessed separately.
Time frame: Baseline (pre-treatment) to 1, 3, 6 and 9 months post-treatment
Usability of the device
Time frame: Baseline - treatment
Subject-reported satisfaction with treatment as assessed by a subject satisfaction questionnaire at 1, 3, 6 and 9 months post-treatment.
Time frame: 1, 3, 6 and 9 months post-treatment
Post-treatment events
Time frame: Up to 14 days post-treatment
Adverse Events
Time frame: Up to 9 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Nilsson, MD, PhD principal investigator
CTC Clinical Trial Consultants AB
Mohammad Alimohammadi, MD, PhD principal investigator
Almo Alo AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DKL crosslinked sodium hyaluronate 23 and Juvéderm Volift™ with lidocaine (Allergan, Inc) in people with Aging, Premature, run by Dr. Korman Laboratories Ltd. at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline (pre-treatment) to 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.