NCT00991198已完成2 期
The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage in Individuals With Multiple Skin Conditions A Double-Blind, Placebo Controlled Comparative Trial
Aria Aesthetics Inc.1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- skin grading evaluation of photodamage
研究概览
简要总结
This study is an evaluation of the role of topical dissolved oxygen to lessen visible signs of photodamage using a select regimen of topical dissolved oxygen containing cosmeceutical products. Evaluation of the overall skin tolerability of topical dissolved oxygen (safety) utilizing the regimen of products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects must be female, 25-60 years old in good general health;
- •Subjects must be Fitzpatrick Types I, II, III, IV, V
- •Subjects must be willing to forgo the use of facial cosmetics (e.g. facial moisturizers,creams, foundations, blush, etc.) during the course of the study.
- •Subjects may ONLY use facial regimen of products provided by sponsor(lipstick, lip gloss, and eye mascara permitted).
排除标准
- •Known sensitivity to any of the test material ingredients.
- •Routine high dosage use of anti-inflammatory medications (aspirin, ibuprofen, corticosteroids), immunosuppressive drugs or antihistamine medications (steroid nose drops and/or eye drops are permitted) (one-8lmg or 325mg aspirin okay) (birth control is okay but needs to be reported).
- •Use of topical OTC/Rx drugs or other cosmetics at the test sites.
- •Immunological disorders such as HIV positive and systemic lupus erythematosus (interview only)
- •Participation in any clinical study within the last four weeks.
- •Pregnant or lactating women (interview only).
- •Damaged skin in or around test sites (including sunburn, uneven skin tones, tattoos, scars or other disfiguration of the test site).
研究组 & 干预措施
A
Experimental
Aria Regimens 0.5% conc
干预措施: Topical oxygen (Drug)
B
Experimental
Aria Regimen (5 products) 0.25% conc
干预措施: Topical oxygen (Drug)
C
Placebo Comparator
Aria Regimen Control without O2
干预措施: placebo (Drug)
结局指标
主要结局
skin grading evaluation of photodamage
时间窗: 8 weeks
次要结局
- stratum corneum hydration (skin capacitance)(8 weeks)
- bioinstrumental assessment of skin "melanin" lightening, and lesional erythematous sites(8 weeks)
- bioinstrumental assessment of skin texture, scaliness (desquamation)(8 weeks)
- punch biopsy histopathologic examination (H&E, and immunohistochemistry for Aquaporin 3, and Filaggrin)(8 weeks)
- RT-PCR collagenase , and hypoxia-inducible factor-1 alpha(8 weeks)
- product performance(8 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A clinical trial to study the wound healing rates in topical oxygen wound therapy with conventional dressing vs conventional dressings alone in diabetic lower limb ulcers.CTRI/2024/06/068317KLEs Dr Prbhakar Kore hospital and medical research centre.60
已完成
不适用
Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical TomographyBreast BiopsyNCT03842358Washington University School of Medicine298
尚未招募
不适用
Effect of associated therapies on gingival treatment in type 2 diabetic patients.RBR-2mdfgdmFaculdade de Odontologia de Araçatuba - FOA/UNESP
已完成
不适用
Effect of Topical Oxygen on healing of Pressure ulcersPressure ulcers.Decubitus ulcer and pressure areaIRCT201602275426N9Vice chancellor for research of Kerman University of Medical Sciences80
已完成
不适用
Pilot Study to Evaluate the Use of OroScience Topical Oral Wound Emulsion in Post Operative Wound HealingOral Surgical ProceduresPainNCT00596141OroScience, Inc.17