An Open Label Pilot Clinical Trial on the Efficacy and Safety of ProOxy Facial Spray (Topical 15% Oxygen Solution) in the Treatment of Moderate Facial Acne Vulgaris Among Filipino Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face.
研究概览
简要总结
This study was conducted to determine the effects and side effects of ProOxy facial spray in the treatment of acne.
详细描述
A study on the effects and side effects of ProOxy facial spray was done. Sixty people were selected and approved to participate in this study. Pictures of the face (frontal,left side and right side) were taken upon acceptance, during and after treatment at 4,8 and 12 weeks intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with acne on their faces only
- •patients who are at least 18 years of age
- •patients who have normal and disease free skin at the dorsal surface of the upper arm.
- •patients who are willing to follow instructions on both the Patch Test Part one and Part Two procedures and to follow scheduled visits.
- •Exclusion Criteria
- •patients with systemic illnesses(such as but not limited to heart disease, hypertension, diabetes, cancer, liver disease, kidney disease)
- •patients with very dark skin color, Fitzpatrick skin type V-VI, who are prone to post=inflammatory hyperpigmentation.
- •patients with intake of oral medications including glucocorticoids or any immuno-suppressants or who have undergone ultraviolet phototherapy for the past 2 weeks prior to the patch test.
- •patients with history of contact dermatitis, dermatographism or anaphylaxis.
- •patients with history of eczematous and inflammatory dermatitis, seborrheic dermatitis and psoriasis.
排除标准
- 未提供
研究组 & 干预措施
ProOxy, Effects and Side Effects in treating acne
Patients are instructed to clean the face with ProOxy facial cleanser and then spray on the face wet enough but not dripping twice daily (upon waking up and before bedtime) for 3 months.
干预措施: ProOxy (Drug)
结局指标
主要结局
Changes in the appearances,sizes of the acne lesions as well as the disappearance of acne on the face.
时间窗: 4,8,12 weeks post application of the spray
Upon acceptance,pictures are taken and acne lesions are identified and counted and after 4,8, and 12 weeks during and after application of ProOxy.
次要结局
未报告次要终点