DandruffNCT05319444
Cleansing Device for the Treatment of Scalp and Hair Conditions
A study testing Off-brand Waterpik® in people with Dandruff and Seborrheic Dermatitis, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dandruff, Seborrheic Dermatitis, Hair Loss
- What is being tested?
- Off-brand Waterpik®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2022to 12 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- Vasectomized partner
- Sexual abstinence
- Barrier method, such as a condom
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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.
- Conditions
- Dandruff, Seborrheic Dermatitis, Hair Loss
- Being tested
- Off-brand Waterpik®
- Medical subject headings
- Dandruff, Dermatitis, Seborrheic, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-brand Waterpik®Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Scalp and one treatment | Experimental | Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up. Receives: Device: Off-brand Waterpik® |
| Healthy Scalp and three treatments | Experimental | Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up. Receives: Device: Off-brand Waterpik® |
| Dandruff and one treatment | Experimental | Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up. Receives: Device: Off-brand Waterpik® |
| Dandruff and three treatments | Experimental | Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up. Receives: Device: Off-brand Waterpik® |
| Hair loss disease and one treatment | Experimental | Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up. Receives: Device: Off-brand Waterpik® |
| Seborrheic Dermatitis with one treatment | Experimental | Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up. Receives: Device: Off-brand Waterpik® |
| Seborrheic Dermatitis and three treatments | Experimental | Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up. Receives: Device: Off-brand Waterpik® |
| Hair loss disease and three treatments | Experimental | Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up. Receives: Device: Off-brand Waterpik® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
Change in Erythema Score
The presence of erythema is rated on a scale of 0-4, where 0 indicates None, 1 indicates Minimal - barely perceptible erythema, 2 indicates Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema, 3 indicates Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red), and 4 indicates Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema. The higher score means a worse outcome.
Measured: 4 weeks
Change in Patient Sensory Assessment of Scalp & Hair Score
This Score is based on 12 descriptions that patients rate 0-10 to assess the condition of their scalp and hair. A higher score means a worse outcome.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start27 May 2022
- Primary completion12 May 2023
- Study completion12 May 2023
Why it stopped: This study has a patent application submitted to the patent office
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DandruffStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronda Farah, MD, Principal investigator, University of Minnesota Medical School Department of DermatologyMaria Hordinsky, MD, Principal investigator, University of Minnesota Medical School Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319444
- Sponsor's protocol ID
- DERM-2021-29445
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2022
- Last updated
- 4 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cleansing Device for the Treatment of Scalp and Hair Conditions
- ClinicalTrials.gov ID
- NCT05319444
- Acronym / sponsor ID
- DERM-2021-29445
- Conditions
- Dandruff, Seborrheic Dermatitis, Hair Loss
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has a patent application submitted to the patent office
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Posted 4 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Healthy Scalp and one treatment | Experimental | Device: Off-brand Waterpik®Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up. |
| Healthy Scalp and three treatments | Experimental | Device: Off-brand Waterpik®Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up. |
| Dandruff and one treatment | Experimental | Device: Off-brand Waterpik®Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up. |
| Dandruff and three treatments | Experimental | Device: Off-brand Waterpik®Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up. |
| Hair loss disease and one treatment | Experimental | Device: Off-brand Waterpik®Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up. |
| Seborrheic Dermatitis with one treatment | Experimental | Device: Off-brand Waterpik®Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up. |
| Seborrheic Dermatitis and three treatments | Experimental | Device: Off-brand Waterpik®Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up. |
| Hair loss disease and three treatments | Experimental | Device: Off-brand Waterpik®Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Dandruff and one treatment, Dandruff and three treatments, Hair loss disease and one treatment, Hair loss disease and three treatments, Healthy Scalp and one treatment, Healthy Scalp and three treatments, Seborrheic Dermatitis and three treatments, Seborrheic Dermatitis with one treatment |
Primary outcome
Change in Adherent Scalp Flaking Scale (ASFS)
Time frame: 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.
2 secondary outcomes
Change in Erythema Score
Time frame: 4 weeks
Change in Patient Sensory Assessment of Scalp & Hair Score
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronda Farah, MD principal investigator
University of Minnesota Medical School Department of Dermatology
Maria Hordinsky, MD principal investigator
University of Minnesota Medical School Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Off-brand Waterpik® in people with Dandruff and Seborrheic Dermatitis, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adherent Scalp Flaking Scale (ASFS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.