Cleansing Device for the Treatment of Scalp and Hair Conditions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Adherent Scalp Flaking Scale (ASFS)
研究概览
简要总结
The objective of this study is to evaluate an improvement of scalp health after the use of an investigational off-label WaterPik and brush device aimed to massage and cleanse the scalp.
详细描述
Seborrheic dermatitis and dandruff are skin conditions that present with common features and respond similarly to treatments. Dandruff involves flaking skin that can cause irritation and itching. Dandruff only involves the scalp, whereas seborrheic dermatitis can occur on the scalp, face, chest, and retro-auricular areas. Seborrheic dermatitis can also result in itching and flaking, as well as inflammation and erythema. Both dandruff and seborrheic dermatitis are known to be harmful to the scalp.
Despite shampoo and washing, one may still continue to have flaking and scale present on the scalp. There are numerous scalp massages and brushes on the consumer market. Waterpik® was FDA approved in 2018 to provide pressured water combined with a powered toothbrush for optimal plaque and particle removal when cleaning the mouth and teeth. Waterpik® now has several products on the market designed for oral health, pet care, and washing in the shower. The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health.
Through the investigational use of the off-label WaterPik® and brush device, the investigators propose the technique of massage and gentle water pressure will reduce seborrheic dermatitis and dandruff on the scalp.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must qualify for one of the following scalp conditions based on clinical opinion of a board-certified dermatologist: healthy scalp, dandruff, seborrheic dermatitis, or hair loss disease
- •All Women of Child Bearing Potential must indicate use of two of the following contraceptive methods. The WaterPik device uses an ultrasonic technology which includes ultrasound. Unnecessary ultrasound is not recommended for pregnant women.
- •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
- •Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
- •Intrauterine device (IUD)
- •Intraurerine hormone-releasing system (IUS)
- •Vasectomized partner
- •Sexual abstinence
- •Barrier method, such as a condom
排除标准
- •Non-English speaking
- •Exclusion related to pregnancy, lactation, or plans to become pregnant over the course of the study (based on self-report from the participant)
- •Current clinical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements
研究组 & 干预措施
Dandruff and three treatments
Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up.
干预措施: Off-brand Waterpik® (Device)
Seborrheic Dermatitis with one treatment
Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up.
干预措施: Off-brand Waterpik® (Device)
Seborrheic Dermatitis and three treatments
Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up.
干预措施: Off-brand Waterpik® (Device)
Hair loss disease and three treatments
Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up.
干预措施: Off-brand Waterpik® (Device)
Dandruff and one treatment
Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up.
干预措施: Off-brand Waterpik® (Device)
Healthy Scalp and one treatment
Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up.
干预措施: Off-brand Waterpik® (Device)
Healthy Scalp and three treatments
Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up.
干预措施: Off-brand Waterpik® (Device)
Hair loss disease and one treatment
Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up.
干预措施: Off-brand Waterpik® (Device)
结局指标
主要结局
Change in Adherent Scalp Flaking Scale (ASFS)
时间窗: 4 weeks
The presence of dandruff flakes adhereing to the scalp in 8 defined areas is rated on a scale of 0-10 per area, where 0 indicates no flakes and 10 indicates heavy flaking. This is combined for total scores ranging from 0-80.
次要结局
- Change in Patient Sensory Assessment of Scalp & Hair Score(4 weeks)
- Change in Erythema Score(4 weeks)