Clinical trial NCT05319444: Cleansing Device for the Treatment of Scalp and Hair Conditions
Official title: Cleansing Device for the Treatment of Scalp and Hair Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dandruff
Seborrheic Dermatitis
Hair Loss
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Adherent Scalp Flaking Scale (ASFS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Erythema Score
timeFrame: 4 weeks
measure: Change in Patient Sensory Assessment of Scalp & Hair Score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota Medical School Department of Dermatology
name: Ronda Farah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota Medical School Department of Dermatology
name: Maria Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: