Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® M in Lip Augmentation

NCT06858007 | Completed

• 1 other identifier: TGMQUA/0224/MD
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The utilization of minimally invasive techniques has brought about a transformative shift in the approach to face rejuvenation, potentially representing one of the most notable advancements in facial plastic surgery in recent times. Originally employed to address the presence of fine lines and wrinkles, the application of fillers has now evolved to encompass the remediation of volume depletion and the enhancement of the aging visage. Over a period of time, the convex shape of the midface region has the potential to undergo a flattening or concave transformation. KOS® M in the dermis regulates water balance, osmotic pressure and ion flow and functions as a sieve, excluding certain molecules, enhancing the extracellular domain of cell surfaces and stabilizes skin structures by electrostatic interactions. The Research Question of the present study is the following: to collect sufficient clinical data to demonstrate compliance with the General Safety and Performance Requirements of KOS® M when used as intended.

Conditions

Lip Augmentation

Keywords

Lip augmentation improvement

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of KOS® M in lip augmentation

  The primary objective of the study is to evaluate the effectiveness of KOS® M in lip augmentation by assessing changes in the Allergan Lip Fullness Scale (ALFS). Response is defined as a ≥1 point improvement in ALFS at 3 months after last treatment. Allergan Lip Fullness Scale - from Minimal (Flat or nearly flat contour; minimal red lip shows) to Very Marked (Very significant red lip shows, lower lip pout, and lip pout)

  3 months

Secondary Outcomes (7)

• Effectiveness on KOS® M in lip augmentation

  3 months

• Effectiveness on KOS® M in lip augmentation

  3 months

• Effectiveness on KOS® M in lip augmentation

  3 months

• Change in the ALFS (Allergan Lip Fullness Scale) Grade from baseline

  1, 3, 6 and 12 months

• Proportion of participants with at least 1-point improvement from baseline on the ALFS

  1,6 and 12 months

Study Arms (1)

KOS® M

OTHER

An open, non-comparative, interventional single-armed clinical trial.

Device: KOS® M

Interventions

KOS® M DEVICE

Delivery of medical device as injection

KOS® M

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent by the subject
• Females and males ≥ 22 years of age
• Scoring 0 (minimal), 1 (mild) and 2 (moderate) on the 5-point Allergan LFS
• Have established a realistic treatment goal that the physician agrees is achievable, i.e., have realistic expectations of aesthetic results
• Ability to follow study instructions and likely to complete all required visits
• Reliable methods of contraception which result in a low failure rate (i.e. less than 1 % per year) for women of childbearing potential, e.g. implants, injectables, combined oral contraceptives, some intrauterine-devices, sexual abstinence or vasectomized partner) for the entire study duration.

You may not qualify if:

• Has Inflamed or infected skin in or near the studied zones
• History of or active autoimmune disease/immune deficiency
• History of any disease resulting in changes of facial contour or edema of the face during the study period
• Significant abnormalities of the lips
• Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments
• 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
• Has undergone oral surgery (e.g., tooth extraction, orthodontia, or implantation) within 6 weeks before enrollment or is planning to undergo any of these procedures during the study
• Has ever undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study
• Has undergone semipermanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L- lactic acid) in the lower face (below the orbital rim) within 24 months before enrollment or is planning to undergo such treatment during the study
• Has undergone temporary dermal filler treatment (e.g., hyaluronic acid or collagen) in the lower face (below the orbital rim) within 12 months before enrollment or is planning to undergo such treatment during the study
• Taking medications and/or substances known to increase coagulation time (e.g., aspirin, ibuprofen, or herbal supplements) 10 days prior to treatment
• Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or non-ablative procedures) anywhere in the face or neck, or Botulinum toxin injections in the lower face (below the orbital rim) within 6 months before enrollment or is planning to undergo any of these procedures during the study
• Prone to hypertrophic scars
• History of allergy to hyaluronic acid or any of the product's components
• History of allergy to lidocaine or local anaesthesia of amide compounds

Sponsors & Collaborators

• Quantum Beauty Kozmetik: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (1)

Clinica Beyond Dental

Timișoara, Timiș County, Romania

Location

Related Publications (3)

• Attenello NH, Maas CS. Injectable fillers: review of material and properties. Facial Plast Surg. 2015 Feb;31(1):29-34. doi: 10.1055/s-0035-1544924. Epub 2015 Mar 12.

  PMID: 25763894 BACKGROUND

• Werschler WP, Fagien S, Thomas J, Paradkar-Mitragotri D, Rotunda A, Beddingfield FC 3rd. Development and validation of a photographic scale for assessment of lip fullness. Aesthet Surg J. 2015 Mar;35(3):294-307. doi: 10.1093/asj/sju025.

  PMID: 25805282 BACKGROUND

• Dayan S, Bruce S, Kilmer S, Dover JS, Downie JB, Taylor SC, Skorupa A, Murphy DK. Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation. Dermatol Surg. 2015 Dec;41 Suppl 1:S293-301. doi: 10.1097/DSS.0000000000000540.

  PMID: 26618456 BACKGROUND

Study Officials

• Behnam D Bayatani

  STUDY CHAIR

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: February 4, 2025
• First Posted: March 5, 2025
• Study Start: June 17, 2025
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)