EUCTR2009-010338-23-DE进行中（未招募）不适用
Intra-individual randomized comparison of the efficacy of two botulinum toxins type A on moderate to severe forehead wrinkles after one injection
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Female Subjects of any race, from 18 to 65 years old;
- •2.Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the Forehead Wrinkles Severity Scale) on both sides of the forehead;
- •3.Negative urine pregnancy test at the Baseline visit for Subjects of childbearing potential;
- •4.Subjects of childbearing potential must practice a highly effective method of contraception during the study;
- •5.Subjects of non-childbearing potential;
- •6.Subjects having read and signed the approved Informed Consent Form prior to any participation in the study;
- •7.Subjects willing and capable of cooperating to the extend and degree required by the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subjects with a washout period for procedure(s)/treatment(s) on the forehead less than (see table below):
- •Retinoid, microdermabrasion, or prescription level glycolic acid treatments2 weeks
- •Non-ablative light treatments (e.g., Intense Pulsed Light, light-emitting diodes)1 month
- •Ablative skin resurfacing
- •Non-ablative dermal treatment for skin tightening (e.g., radio-frequency treatments)6 months
- •Treatment with a BoNT-A12 months
- •Soft tissue augmentation (e.g. biodegradable products as collagen or hyaluronic acid preparations)24 months
- •2.Subjects who undergone a surgical facelift;
- •3.Permanent or semi-permanent dermal fillers in the forehead area;
- •4.Inability to substantially lessen forehead wrinkles by physically spreading them apart;
- •5.Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts);
- •6.Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics;
- •7.Concurrent treatment that, in the Evaluator’s opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments;
- •8.Active infection in the forehead area (e.g. acute acne lesions or ulcers);
- •9.Current facial palsy;
- •10.Marked facial asymmetry, excessive dermatochalasis, brow ptosis, deep dermal scarring or thick sebaceous skin;
- •11.Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert Syndrome or Amyotrophic lateral sclerosis);
- •12.Clinically diagnosed anxiety disorder or any significant psychiatric disorder (e.g. depression) that, in the opinion of the Evaluator, might interfere with the Subject’s participation in the study;
- •13.Current history of chronic drug or alcohol abuse;
- •14.Presence of any other condition (e.g. neuromuscular disorder or other disorder that could interfere with neuromuscular function) or circumstance that, in the judgment of the Evaluator, might increase the risk to the Subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study;
- •15.Pregnant women, nursing mothers, or women who are planning pregnancy during the study;
- •16.Participation in another investigational treatment or device research study within 30 days of enrolment;
- •17.Adult Subjects under guardianship, hospitalised Subjects in a public or private institution for a reason other than the research, and Subjects deprived of freedom.
研究者
相似试验
进行中（未招募）
不适用
etude comparative randomisee intra-individuelle de l'efficacite du traitement d'hidradenite suppuree ou maladie de verneuil par injections sous cutanee de toxine botulinique versus placebo - verneuil2006’hidradénite suppurée est une affection des glandes sudorales apocrines. Les glandes apocrines sont sous la dépendance des terminaisons nerveuses orthosympathiques . Le mécanisme d’action de la toxine botulinique est le blocage de la transmission cholinergique des glandes sudorales . Nous avons rapporter l’efficacité de la toxine botulinique pour le traitement de la maladie de Verneuil et nous souhaitons vérifier l’efficacité de ce traitement par une étude en double aveugleEUCTR2007-000534-39-FRacep16
尚未招募
不适用
To compare the efficacy of Dhurdhurapatradi hair oil with or without Amrabeej and Haritaki Churna head aplication(shirolepa) in the treatment of Dandruff.CTRI/2022/10/046699PDEAs College of Ayurved and Research centre Nigadi Pune
尚未招募
4 期
Effects of co2 on arterial oxygenation during one lung ventilation.CTRI/2024/04/065019Sms medical college
尚未招募
Unknown
Study To Compare The Effectiveness of Centesimal Versus Fifty Millesimal Scale In The Management of Polycystic Ovarian SyndromeCTRI/2023/04/051971ehru Homoeopathic Medical College and Hospital University of Delhi
已完成
3 期
To determine the efficacy and safety of 1000 IU/ ml topical solution of heparin sodium versus 200 IU/G heparin sodium gel in the management of post infusion superficial thrombophlebitis.CTRI/2010/091/002947Troikaa Pharmaceuticals Ltd200