A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation

NCT07204691 | Not Yet Recruiting

• 1 other identifier: CLSHA+L-DKL-CS001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lip Augmentation

Keywords

lips; hyaluronic acid; dermal filler; esthetics

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  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.

  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.

  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.

  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.

  Baseline (prior to treatment) to Week 4, 8, 12, 16, 24, and 48.

Study Arms (1)

Treatment

EXPERIMENTAL

DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler (RadiaNt Soft Lidocaine)

Device: DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler

Interventions

DKL crosslinked sodium hyaluronate 20 mg/mL + Lidocaine 0.3% dermal filler DEVICE

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 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.

Sponsors & Collaborators

• Dr. Korman Laboratories Ltd.: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (2)

Clinical Trial Consultants AB (CTC) GoCo

Mölndal, SE-431 53, Sweden

Location

CTC Stockholm

Solna, SE-171 64, Sweden

Location

Central Study Contacts

Mingyan Hallén, MD, PhD

CONTACT

+46 (0)70 330 23 62; mingyan.hallen@ctc-ab.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: September 24, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)