DRKS00025937已完成未知
Prospective evaluation of the efficacy and safety of a dermal filler family - PP_UCderm-01
niCare GmbH0 个研究点目标入组 137 人开始时间: 2021年7月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 137
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 120 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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