New lip filler shows promise in restoring volume

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.