Study Stopped
This study has a patent application submitted to the patent office
Cleansing Device for the Treatment of Scalp and Hair Conditions
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
December 17, 2025
December 1, 2025
6 months
March 31, 2022
December 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Adherent Scalp Flaking Scale (ASFS)
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.
4 weeks
Secondary Outcomes (2)
Change in Erythema Score
4 weeks
Change in Patient Sensory Assessment of Scalp & Hair Score
4 weeks
Study Arms (8)
Healthy Scalp and one treatment
EXPERIMENTALParticipants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up.
Healthy Scalp and three treatments
EXPERIMENTALParticipants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up.
Dandruff and one treatment
EXPERIMENTALParticipants with dandruff who will receive one treatment with the device and complete one in-person follow-up.
Dandruff and three treatments
EXPERIMENTALParticipants with dandruff who will receive three treatments with the device and complete one in-person follow-up.
Hair loss disease and one treatment
EXPERIMENTALParticipants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up.
Seborrheic Dermatitis with one treatment
EXPERIMENTALParticipants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up.
Seborrheic Dermatitis and three treatments
EXPERIMENTALParticipants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up.
Hair loss disease and three treatments
EXPERIMENTALParticipants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- Non-English speaking
- Current clinical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronda Farah, MD
University of Minnesota Medical School Department of Dermatology
- PRINCIPAL INVESTIGATOR
Maria Hordinsky, MD
University of Minnesota Medical School Department of Dermatology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2022
First Posted
April 8, 2022
Study Start
May 1, 2026
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share