DRKS00025699已完成4 期
Open-label, multicenter, uncontrolled, randomized, post market clinical follow-up (PMCF) study to confirm effectiveness and safety of Belotero® Revive in facial skin revitalization and photo-damaged skin treatment - BELOVE 2.0
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 159
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 25 Years 至 45 Years（—）
- 性别
- All
入选标准
- •1. Written informed consent obtained from the subject;
- •2. Female or male = 25 to 45 years old;
- •3. Subjects with early signs of facial photo-damaged skin (as assessed on investigators judgement based on i.e., uneven skin tone, fine lines, dehydrated skin) who is looking for an improvement of their skin quality/skin revitalization and aesthetic appearance;
- •4. Subject is willing to abide from all (aesthetic) facial procedures (e.g., other dermal fillers outside of this study, toxin treatments, any resurfacing procedures e.g., facial ablative or fractional laser, microdermabrasion, chemical peels, non-invasive skin-tightening [e.g., Ultherapy®], and surgical procedures) in the area to be treated during participation in the study;
- •5. Woman of childbearing potential must be using a highly effective method of birth control.
排除标准
- •Subjects who had:
- •1. A recent or current history of inflammatory skin disease (e.g., acne), infection, cancerous/pre-cancerous lesion, unhealed wound in the proposed treatment areas. Have a history of systemic granulomatous diseases active or inactive (e.g., sarcoid, Wegeners, tuberculosis, etc.) or connective tissue diseases (e.g., lupus, dermatomyositis, etc.) with the potential to interfere with the study results or increase the risk of adverse events (AEs);
- •2. Actinic damaged skin, severe solar elastosis and/or premature aging skin in the area to be treated;
- •3. Begun use of any new over-the-counter or prescription, oral or topical, anti-wrinkle products in the target areas within 90 days prior to enrollment or is planning to begin use of such products during participation in the study.
- •4. A history of the following cosmetic treatments in the area(s) to be treated:
- •4.1 Skin tightening procedure within the past 12 months (e.g., Ultherapy);
- •4.2 Injectable filler of any type within the past:
- •-12 months for hyaluronic acid fillers (e.g., Belotero® Balance);
- •-12 months for calcium hydroxyapatite
- •fillers (e.g., Radiesse®);
- •-24 months for poly-L-lactic acid fillers (e.g., Sculptra®);
- •-Ever been treated with silicone, polymethyl methacrylate (PMMA), fat injections, or permanent dermal fillers (e.g., Silicone).
- •4.3 Botulinumtoxins within the past 3 months;
- •4.4 Ablative resurfacing laser treatment within the past 24 months;
- •4.5 Nonablative, rejuvenative laser or light treatment within the past 6 months;
- •4. 6 Surgical dermabrasion or deep facial peels within the past two years.
- •5. A propensity towards pigmentary skin changes, such as hyper- or hypopigmentation in the face, keloid formation, or hypertrophic scarring.
研究者
相似试验
进行中（未招募）
不适用
Randomized, open-label, controlled and multicenter trial on a new pattern of Paroxetine up-titration for Panic Disorder. Comparison between two different dose regimens. - NDMedDRA version: 9.1Level: LLTClassification code 10033666Term: Panic disorderPanic DisorderEUCTR2007-000051-34-ITITALFARMACO
进行中（未招募）
不适用
Multicenter, open-label, randomized, uncontrolled study to evaluate inhibition of ovulation of two transdermal patch formulations containing 0.55 mg ethinylestradiol and either 1.05 or 2.1 mg gestodene in healthy young female volunteers over a period of 3 treatment cycles - Inhibition of ovulation, patch, ethinylestradiol and gestodeneThe trial will be performed in healthy female volunteers. The indended indication is female contraception.EUCTR2008-001198-13-DEBayer HealthCare AG/Bayer Schering Pharma AG
进行中（未招募）
不适用
on-blinded phase II study to compare the efficacy and safety of CetuGEX™ plus chemotherapy with cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckstage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckMedDRA version: 14.1Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003695-13-ITGlycotope GmbH240
进行中（未招募）
1 期
on-blinded phase II study to compare the efficacy and safety of CetuGEX? plus chemotherapy with cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckstage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckMedDRA version: 14.1Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003695-13-ESGlycotope GmbH240
进行中（未招募）
1 期
on-blinded phase II study to compare the efficacy and safety of CetuGEX™ plus chemotherapy with cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neckEUCTR2013-003695-13-PLGlycotope GmbH240