L80-L99
Conditions
Interventions
Group 1: (a) UCderm Impression (1 x 1mL, 26mg/mL with Lidocaine)
Group 2: (b) UCderm Fine (1 x 1mL, 26mg/mL with Lidocaine)
Group 3: (c) UCderm Volume (1 x 1mL, 26mg/mL with Lidocaine)
Group 4: (d) UC
Sponsors
UniCare GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: • at least 18 years of age • subjects with small, moderate to severe folds as determined by a Wrinkle Severity Score or facial pores and/or subjects who want to have a volumization/augmentation of the lips (small wrinkles/folds are defined as so-called skin crease lines mainly appearing around the mouth and eyes): • UCderm impression to reduce fine lines: WSRS grade 2 or 3 • UCderm fine for light facial wrinkles: WSRS grade 2 or 3 • UCderm volume for medium facial wrinkles and lip augmentation: LFGS grade 3 or 4 • UCderm lift for deep facial wrinkles: WSRS grade 3, 4 or 5 • no hypersensitivity • refrain from undergoing other anti-wrinkle and/or lip augmentation treatment in the facial areas (such as botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels and/or non¬ invasive skin-tightening (e.g., ultrasound, radiofrequency, intense pulsed light treatment, etc.)) before and during the study period or any other former surgical intervention in the treated area • Females of childbearing potential are required to have a negative urine pregnancy test and to use highly effective and reliable contraception while participating in the study • Presence of a written declaration of consent • Ability to consent of the patient and the existence of the respective informed consent
Exclusion criteria
Exclusion criteria: • history of porphyria • development of keloids • uncontrolled or untreated epilepsy • autoimmune or rheumatic disease • frequent amygdalitis • allergy to lidocaine or hypersensitivity to HA • history of anaphylaxis, atopy or multiple severe allergies • pregnancy or breastfeeding • prior, current or planned immune therapy • history of a neurological disorder • fibromyalgia • connective tissue disease • diabetes mellitus • prior, current or planned anticoagulant (e.g. aspirin, non- steroidal anti-inflammatory drugs), or antiplatelet therapy or blood clotting disorders • bleeding disorders • wound healing disorders • inflammation or infection in the treated area (e.g. acne, herpes, psoriasis) • patients with scars, tattoos, acute sun damages, open wounds or lesions in the treated area • incipient or existing influenza infections • acute systemic infections • local anaesthetics • acute articular rheumatism with cardiac localization • treatment with drugs tending to slow down or inhibit the liver metabolism (e.g. cimetidine, beta-blockers) • cardiac arrhythmia • tendency to develop hypertrophic scarring • previous or concomitant (planned) cosmetic procedure or tissue augmentation in the treated area (such as botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels and/or non-invasive skin-tightening (e.g., ultrasound, radiofrequency, intense pulsed light treatment, etc.)) or any other former surgical intervention in the treated area • clinically significant organic disease, condition, illness, or circumstance that would compromise participation in the study • persons who have been placed in an institution as a result of an administrative or judicial order • persons who are dependent on the sponsor, investigator or the investigation site
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Reduced measurable effect (all products) Pore evaluation for UCderm Impression Contour effect for UCderm Lift Improved skin appearance (all products) WSRS for UCderm Volume Patient satisfaction (all products) Pain (all products) by means of the Visual Analogue Scale (VAS) Investigator satisfaction (all products) Safety evaluation: (all products) | — |
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint of this clinical investigation is the product’s efficacy measured by the positive volume augmentation. This is represented for UCderm Fine, UCderm Impression, UCderm Lift in a reduction of at least one point on the Wrinkle Severity Rating Scale (WSRS) from baseline to three months and respectively, for UCderm Volume in an augmentation of at least one point on the Lip Fulness Grading Scale (LFGS) from baseline to three months. | — |
Countries
Germany
Contacts
Public ContactMaja Hofmann
Charité – Universitätsmedizin BerlinÄsthetik und Lasermedizin
Outcome results
None listed