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

Inclusion criteria

• 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.

Exclusion criteria

• 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
• Known case of porphyria
• Pregnancy or lactation
• Have a condition or be in a situation that, in the physician's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
• Untreated epilepsy
• Hypersensitivity to gram positive bacterial proteins as hyaluronic acid is produced by Streptococcus type bacteria.