A Single-center, Double-blind, Controlled Study to Evaluate the Effect of Next Science™ Acne Cream on Mild to Moderate Facial Acne in Adult Females Over 6 Months.
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Reduction in Lesion Count
研究概览
简要总结
To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.
详细描述
This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Science™ acne cream 2x or Next Science™ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ages 18 and above
- •Has 20 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment.
- •In the area to be treated, has no significant facial dermatological conditions other than acne (as determined by the investigator) that would interfere with any study treatment or procedure
- •Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation
- •Agrees to refrain from professional facial treatments during their trial participation.
- •Agrees to avoid tanning booth use and minimize sun exposure during their trial participation.
- •Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site
- •Is able to read, understand and sign the informed consent document and communicate with study staff and investigator.
排除标准
- •Has more than 2 nodules/cystic acne lesions on the face
- •Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients
- •Has any history of skin malignancy
- •Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization.
- •Has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization).
- •Has had any professional facial treatments in the 14 days prior to randomization.
- •Has received any investigational treatment in the 30 days prior to randomization.
- •Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.
研究组 & 干预措施
Acne cream 1x
Twice-daily facial applications of the 1X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months.
干预措施: Acne cream 1X (Drug)
Acne cream 2x
Twice-daily facial applications of the 2X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months.
干预措施: Acne cream 2X (Drug)
结局指标
主要结局
Reduction in Lesion Count
时间窗: Baseline versus 6 months
Inflammatory acne lesions with both study acne cream products after 6 months of treatment compared to baseline. This will be measured as the mean percent change from baseline to week 24 in the inflammatory lesion count.
次要结局
- Inflammatory Lesion count over time(weeks 6, 12, 18, and 24)
- Non-inflammatory acne lesion over time(weeks 6, 12, 18, and 24)
- Investigator Global Assessment over time(weeks 6, 12, 18, and 24)
- Treatment Areas over time(weeks 6, 12, 18, and 24)
- Quality of Life over time(weeks 6, 12, 18, and 24)