Cleansing Device for the Treatment of Scalp and Hair Conditions
NCT ID: NCT05319444
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
40 participants
INTERVENTIONAL
2026-05-01
2026-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Healthy Scalp and one treatment
Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up.
Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
Healthy Scalp and three treatments
Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up.
Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
Dandruff and one treatment
Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up.
Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
Dandruff and three treatments
Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up.
Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
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.
Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
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.
Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
Seborrheic Dermatitis and three treatments
Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up.
Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
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.
Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
Interventions
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Off-brand Waterpik®
Study staff will use the Waterpik® device and brush for approximately two to five minutes on the participant's scalp until all scale and other debris appears to be resolved. Their scalp will then be rinsed and gently dried with a towel.
The off-label design utilizes the Waterpik® device, but with adjustments optimized for scalp health. The device settings are adjustable during the treatment, ranging from settings of 2-10. Study staff plan to utilize the setting of 10 unless the participant indicates discomfort. Investigators attached a small Losophy brush in replacement of the Waterpik® toothbrush. The small Losophy brush was connected to the device via PVC heat shrink and a hole was drilled on the brush in order to deliver water while simultaneously utilizing the brush on the scalp.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Ronda Farah, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota Medical School Department of Dermatology
Maria Hordinsky, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota Medical School Department of Dermatology
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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DERM-2021-29445
Identifier Type: -
Identifier Source: org_study_id