Cleansing Device for the Treatment of Scalp and Hair Conditions

University of Minnesota (UMN)

Status: Suspended

Conditions: Hair Loss; Dandruff; Seborrheic Dermatitis

Treatments: Device: Off-brand Waterpik®

Study type: Interventional

Funder types: Other

Identifiers

NCT05319444

DERM-2021-29445

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 8 patient groups

Healthy Scalp and one treatment

Experimental group

Description:

Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up.

Treatment:

Device: Off-brand Waterpik®

Healthy Scalp and three treatments

Experimental group

Description:

Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up.

Treatment:

Device: Off-brand Waterpik®

Dandruff and one treatment

Experimental group

Description:

Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up.

Treatment:

Device: Off-brand Waterpik®

Dandruff and three treatments

Experimental group

Description:

Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up.

Treatment:

Device: Off-brand Waterpik®

Hair loss disease and one treatment

Experimental group

Description:

Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up.

Treatment:

Device: Off-brand Waterpik®

Seborrheic Dermatitis with one treatment

Experimental group

Description:

Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up.

Treatment:

Device: Off-brand Waterpik®

Seborrheic Dermatitis and three treatments

Experimental group

Description:

Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up.

Treatment:

Device: Off-brand Waterpik®

Hair loss disease and three treatments

Experimental group

Description:

Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up.

Treatment:

Device: Off-brand Waterpik®