A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume Loss

Inclusion criteria

• Subject's age 25 to 70.
• Subject will receive an injection of the medical device 'Alexa Medium' manufactured by Diaco Biofarmaceutici S.r.l., Italy for correction of the lips volume loss within accepted cosmetological practice.
• Subject's lips requiring correction of the lips volume loss according to the Investigator's judgement.
• The subject has established a realistic aesthetic improvement goal that the Investigator agrees is achievable, i.e., have realistic expectations of aesthetic results.
• Subject willing to have photographs of the face taken.
• Subject psychologically able to understand the Investigation related information and to give a written informed consent.
• Subject able and agreeing to follow Investigation procedures, instructions and likely to complete all required visits.
• The subject agreed to participate in the Investigation and signed the Informed Consent Form.

Exclusion criteria

• Subject's age less than 25 or more than 70.
• Subject tends to develop hypertrophic scarring.
• Subjects has known hypersensitivity to cross-linked hyaluronic acid.
• Subjects has history of severe and/or multiple allergies.
• Subjects has history of herpetic rash.
• Subject has impaired haemostatic function.
• Subject is on anticoagulant medication(s) or is using substances that can prolong bleeding.
• Subject has present or past history of autoimmune disease or autoimmune deficiency.
• Subject is undergoing immunosuppressive therapy.
• Subject has acute rheumatic fever with heart complications.
• Subject has tumour in area of the IMD application.
• Subject has active tuberculosis.
• Subject with presence of any other chronic disease that in the opinion of the Investigator may interfere with the outcome of the Investigation.
• Subject is a pregnant or breastfeeding women.
• Subject is presenting with cutaneous inflammatory and/or infectious diseases (acne, herpes, etc.) in area of the IMD application.
• Subject plans laser correction, deep chemical peels or dermabrasion during the potential participation in this Investigation.
• Subject has undergone recently laser correction, deep chemical peels, dermabrasion or surface peels, so the inflammatory reaction from the peel is significant.
• Subject has a permanent implant in the area of the IMD application.
• Subject has already injected more than 18 mL of dermal fillers per 60 kg of body mass per year.
• Subject refuses or is suspected of inability to comply with the requirements of the CIP.
• Subject has difficulty understanding the language in which the informed consent is written.
• Any other reason that the Investigator believes prevents the subject from participating in the Investigation (including suspicion of body dysmorphic disorder).
• Subject takes part in the other Investigation.