Lip AugmentationNCT07204691
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
A study testing DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler in people with Lip Augmentation, run by Dr. Korman Laboratories Ltd. at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesSweden
- Study dates
- 24 Sep 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to 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 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.
Who cannot join
- 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.
- 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.
Show all 29Show fewer
- 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.
- 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. Subjects planning to undergo extensive dental procedures such as dental implants, multiple tooth extractions, or oral surgery should not participate. Minor dental procedures such as teeth cleaning and repair of caries are not exclusionary.
- 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 clinical investigation (subjects who have been on a stable regimen of such products for at least 90 days are eligible for the clinical investigation and must continue their regimen throughout the clinical investigation.)
- 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 known to increase coagulation time (e.g., herbal supplements with garlic or ginkgo) within 10 days of undergoing clinical investigation device injections.
- 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. Subjects 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 lesions at the baseline visit.
- Subjects 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Clinical Trial Consultants AB (CTC) GoCo
Mölndal, SE-431 53
Mingyan Hallén, MD PhD, +46 (0)70 330 23 62, mingyan.hallen@ctc-ab.se
- Recruiting
CTC Stockholm
Solna, SE-171 64
Kaveh Azizi, MD, +46 (0)76 140 56 21, kaveh.azizi@ctc-ab.se
About this study
Official title: A Single-arm, Open-label Clinical Investigation to Evaluate the Safety and Performance of DKL Crosslinked Sodium Hyaluronate 20 mg/mL + Lidocaine 0.3% Dermal Filler for Lip Augmentation
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.
Read the detailed description
This is a single-arm, open-label, multi-center clinical investigation to evaluate the safety, performance, and usability of DKL crosslinked hyaluronic acid 20 mg/mL + lidocaine 0.3% for lip augmentation in healthy male and female volunteers with thin lips. Eligible participants will undergo treatment with crosslinked hyaluronic acid 20 mg/mL + lidocaine 0.3% injected into the lips for lip augmentation. Each participant will act as his/her own control. The improvement in lip appearance over time will be evaluated.
- Conditions
- Lip Augmentation
- Being tested
- DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler
- Keywords
- lips, hyaluronic acid, dermal filler, esthetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal fillerDevice
DKL crosslinked sodium hyaluronate 20 mg/mL + lidocaine 0.3% dermal filler is an injectable sterile, non-pyrogenic gel composed of crosslinked sodium hyaluronate of a non-animal origin and lidocaine in a phosphate-buffered saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler (RadiaNt Soft Lidocaine) Receives: Device: DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lip Fullness Grading Scale (LFGS) score from baseline to 8 weeks after treatment.
The LFGS is a validated 5-point photonumeric rating scale that quantifies lip fullness on a scale ranging from very thin (0) to full (4).
Measured: Baseline (prior to treatment) to Week 8
Secondary outcomes (13)
Change in Lip Fullness Grading Scale (LFGS) score from baseline to 4, 12, 16, 24 and 48 weeks.
The LFGS is a validated 5-point photonumeric rating scale that quantifies lip fullness on a scale ranging from very thin (0) to full (4).
Measured: Baseline (prior to treatment) to Week 4, 12, 16, 24 and 48.
The percentage of subjects who had an improvement of at least one point in the LFGS score from baseline to 4, 8, 12, 16, 24, and 48 weeks.
The LFGS is a validated 5-point photonumeric rating scale that quantifies lip fullness on a scale ranging from very thin (0) to full (4).
Measured: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
Investigator-rated aesthetic improvement in appearance according to the Global Aesthetic Improvement Scale (GAIS) at 4, 8, 12, 16, 24, and 48 weeks after the initial treatment.
The GAIS is a 5-point scale rating global aesthetic improvement in appearance. The rating categories range from 'worse' to 'very much improved'.
Measured: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
Percentage of responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Investigator-rated GAIS at 4, 8, 12, 16, 24, and 48 weeks after the initial treatment.
The GAIS is a 5-point scale rating global aesthetic improvement in appearance. The rating categories range from 'worse' to 'very much improved'.
Measured: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
Subject-rated aesthetic improvement in appearance according to GAIS at 4, 8, 12, 16, 24, and 48 weeks after the initial treatment.
The GAIS is a 5-point scale rating global aesthetic improvement in appearance. The rating categories range from 'worse' to 'very much improved'.
Measured: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
Percentage of responders defined as at least "improved" (improved, much improved, very much improved) as assessed by subject-rated GAIS at 4, 8, 12, 16, 24, and 48 weeks after the initial treatment.
The GAIS is a 5-point scale rating global aesthetic improvement in appearance. The rating categories range from 'worse' to 'very much improved'.
Measured: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
The intensity of pain during the initial injection and touch-up, evaluated on a numerical rating scale (NRS) ranging from 1 (no pain at all) to 10 (worst pain ever possible).
The NRS measures the intensity of pain from 1 (no pain at all) to 10 (worst pain ever possible).
Measured: Baseline (initial treatment), 4 weeks (touch-up, if applicable)
Frequency, intensity, and duration of pre-defined expected post-treatment events collected using a subject diary for 14 days post-treatment.
The frequency, intensity, and duration of pre-defined expected post-treatment events collected using a subject diary.
Measured: From baseline to Week 2; if touch up is done: From Week 4 to Week 6
Frequency, intensity, and duration of adverse events (AEs) throughout the clinical investigation and up to 48 weeks.
The frequency, intensity, and duration of adverse events.
Measured: Baseline to Week 48
Incidence of device deficiencies (DDs).
The incidence of DDs.
Measured: Baseline to Week 4
Lip function, sensation, texture, firmness, and movement/function, before injection and at 4, 8, 12-, 16-, 24-, and 48 weeks post-baseline.
Lip function, sensation, texture, firmness, and movement/function will be assessed as normal or abnormal.
Measured: Baseline to Week 4, 8, 12, 16, 24, and 48.
Subject satisfaction using the validated FACE-Q scales: • Satisfaction with Lips • Satisfaction with Outcome
Satisfaction with Lips is a 10-item scale measures the appearance of the lips with items that ask about size, shape, and fullness, as well as how their lips suit their face and how the lips look when smiling. The answers range from very dissatisfied (1), to very satisfied (4).
Satisfaction with Outcome is a 6-item scale measures satisfaction with the result of a facial procedure. The answers range from agree (1) to disagree (4).
Measured: Baseline to Week 4, 8, 12, 16, 24, and 48 (Satisfaction with outcome will not be assessed at baseline).
Investigator-reported usability of the device
A usability questionnaire will be completed by each of the Treating Investigators.
Measured: Week 4 (after completing the treatment of all subjects)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start24 Sep 2025
- Primary completion12 Feb 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lip AugmentationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Korman Laboratories Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204691
- Sponsor's protocol ID
- CLSHA+L-DKL-CS001
- Status last verified
- May 2026
- First submitted
- 24 Sep 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Investigation to Evaluate the Safety and Performance of DKL Crosslinked Sodium Hyaluronate 20 mg/mL + Lidocaine 0.3% Dermal Filler for Lip Augmentation
- ClinicalTrials.gov ID
- NCT07204691
- Acronym / sponsor ID
- CLSHA+L-DKL-CS001
- Conditions
- Lip Augmentation
- Keywords
- lips, hyaluronic acid, dermal filler, esthetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Dr. Korman Laboratories Ltd.Industry (pharma, biotech, devices)
- Collaborators
- CTC Clinical Trial Consultants AB
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 2 Oct 2025 (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 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.
Detailed description
This is a single-arm, open-label, multi-center clinical investigation to evaluate the safety, performance, and usability of DKL crosslinked hyaluronic acid 20 mg/mL + lidocaine 0.3% for lip augmentation in healthy male and female volunteers with thin lips. Eligible participants will undergo treatment with crosslinked hyaluronic acid 20 mg/mL + lidocaine 0.3% injected into the lips for lip augmentation. Each participant will act as his/her own control. The improvement in lip appearance over time will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal fillerDKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler (RadiaNt Soft Lidocaine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
- 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.
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 20 mg/mL + Lidocaine 0.3% dermal fillerDKL crosslinked sodium hyaluronate 20 mg/mL + lidocaine 0.3% dermal filler is an injectable sterile, non-pyrogenic gel composed of crosslinked sodium hyaluronate of a non-animal origin and lidocaine in a phosphate-buffered saline solution. | Device | Treatment |
Primary outcome
Change in Lip Fullness Grading Scale (LFGS) score from baseline to 8 weeks after treatment.
Time frame: Baseline (prior to treatment) to Week 8
The LFGS is a validated 5-point photonumeric rating scale that quantifies lip fullness on a scale ranging from very thin (0) to full (4).
13 secondary outcomes
Change in Lip Fullness Grading Scale (LFGS) score from baseline to 4, 12, 16, 24 and 48 weeks.
Time frame: Baseline (prior to treatment) to Week 4, 12, 16, 24 and 48.
The percentage of subjects who had an improvement of at least one point in the LFGS score from baseline to 4, 8, 12, 16, 24, and 48 weeks.
Time frame: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
Investigator-rated aesthetic improvement in appearance according to the Global Aesthetic Improvement Scale (GAIS) at 4, 8, 12, 16, 24, and 48 weeks after the initial treatment.
Time frame: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
Percentage of responders defined as at least "improved" (improved, much improved, very much improved) as assessed by the Investigator-rated GAIS at 4, 8, 12, 16, 24, and 48 weeks after the initial treatment.
Time frame: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
Subject-rated aesthetic improvement in appearance according to GAIS at 4, 8, 12, 16, 24, and 48 weeks after the initial treatment.
Time frame: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
Percentage of responders defined as at least "improved" (improved, much improved, very much improved) as assessed by subject-rated GAIS at 4, 8, 12, 16, 24, and 48 weeks after the initial treatment.
Time frame: Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.
The intensity of pain during the initial injection and touch-up, evaluated on a numerical rating scale (NRS) ranging from 1 (no pain at all) to 10 (worst pain ever possible).
Time frame: Baseline (initial treatment), 4 weeks (touch-up, if applicable)
Frequency, intensity, and duration of pre-defined expected post-treatment events collected using a subject diary for 14 days post-treatment.
Time frame: From baseline to Week 2; if touch up is done: From Week 4 to Week 6
Frequency, intensity, and duration of adverse events (AEs) throughout the clinical investigation and up to 48 weeks.
Time frame: Baseline to Week 48
Incidence of device deficiencies (DDs).
Time frame: Baseline to Week 4
Lip function, sensation, texture, firmness, and movement/function, before injection and at 4, 8, 12-, 16-, 24-, and 48 weeks post-baseline.
Time frame: Baseline to Week 4, 8, 12, 16, 24, and 48.
Subject satisfaction using the validated FACE-Q scales: • Satisfaction with Lips • Satisfaction with Outcome
Time frame: Baseline to Week 4, 8, 12, 16, 24, and 48 (Satisfaction with outcome will not be assessed at baseline).
Investigator-reported usability of the device
Time frame: Week 4 (after completing the treatment of all subjects)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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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.
2 sites 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 20 mg/mL + Lidocaine 0.3% dermal filler in people with Lip Augmentation, run by Dr. Korman Laboratories Ltd. at 2 sites 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 5 inclusion and 29 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: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingyan Hallén, MD, PhD (+46 (0)70 330 23 62, mingyan.hallen@ctc-ab.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lip Fullness Grading Scale (LFGS) score from baseline to 8 weeks after treatment. (time frame: Baseline (prior to treatment) to Week 8). 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 15 May 2026.