DRKS00025937
Completed
未知
Prospective evaluation of the efficacy and safety of a dermal filler family - PP_UCderm-01
niCare GmbH0 sites137 target enrollmentJuly 23, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- L80-L99
- Sponsor
- niCare GmbH
- Enrollment
- 137
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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