An interventional study of Off-brand Waterpik® in Dandruff, Seborrheic Dermatitis and Hair Loss, sponsored by University of Minnesota. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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.
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.
58 studies on the registry are indexed under Dermatitis, Seborrheic; 7 are open to participants now.
This study's enrollment of 2 is below the median of 77 across 47 interventional studies indexed under Dermatitis, Seborrheic.
Browse Dermatitis, Seborrheic studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All Women of Child Bearing Potential must indicate use of two of the following methods. The WaterPik device uses an ultrasonic technology which includes ultrasound. Unnecessary ultrasound is not recommended for pregnant women.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up.
Device: Off-brand Waterpik®
Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up.
Device: Off-brand Waterpik®
Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up.
Device: Off-brand Waterpik®
Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up.
Device: Off-brand Waterpik®
Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up.
Device: Off-brand Waterpik®
Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up.
Device: Off-brand Waterpik®
Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up.
Device: Off-brand Waterpik®
Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up.
Device: 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.
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.
Time frame: 4 weeks
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.
Time frame: 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.
Time frame: 4 weeks
| Milestone | Healthy Scalp and One Treatment | Healthy Scalp and Three Treatments | Dandruff and One Treatment | Dandruff and Three Treatments | Hair Loss Disease and One Treatment | Seborrheic Dermatitis With One Treatment | Seborrheic Dermatitis and Three Treatments | Hair Loss Disease and Three Treatments |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Study abandoned | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over From randomization through each participant's final study contact, up to 50 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Healthy Scalp and One Treatment | — | — | — |
| Healthy Scalp and Three Treatments | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Dandruff and One Treatment | — | — | — |
| Dandruff and Three Treatments | — | — | — |
| Hair Loss Disease and One Treatment | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Seborrheic Dermatitis With One Treatment | — | — | — |
| Seborrheic Dermatitis and Three Treatments | — | — | — |
| Hair Loss Disease and Three Treatments | — | — | — |
No participants enrolled in the six arms with zero participants
| Age, Categorical(Participants) | Healthy Scalp and One Treatment | Healthy Scalp and Three Treatments | Dandruff and One Treatment | Dandruff and Three Treatments | Hair Loss Disease and One Treatment | Seborrheic Dermatitis With One Treatment | Seborrheic Dermatitis and Three Treatments | Hair Loss Disease and Three Treatments | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | — | 0 | — | — | 0 | — | — | — | 0 |
| Between 18 and 65 years | — | 1 | — | — | 1 | — | — | — | 2 |
| >=65 years | — | 0 | — | — | 0 | — | — | — | 0 |
| Sex: Female, Male(Participants) | Healthy Scalp and One Treatment | Healthy Scalp and Three Treatments | Dandruff and One Treatment | Dandruff and Three Treatments | Hair Loss Disease and One Treatment | Seborrheic Dermatitis With One Treatment | Seborrheic Dermatitis and Three Treatments | Hair Loss Disease and Three Treatments | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | — | 0 | — | — | 1 | — | — | — | 1 |
| Male | — | 1 | — | — | 0 | — | — | — | 1 |
| Race (NIH/OMB)(Participants) | Healthy Scalp and One Treatment | Healthy Scalp and Three Treatments | Dandruff and One Treatment | Dandruff and Three Treatments | Hair Loss Disease and One Treatment | Seborrheic Dermatitis With One Treatment | Seborrheic Dermatitis and Three Treatments | Hair Loss Disease and Three Treatments | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | — | 0 | — | — | 0 | — | — | — | 0 |
| Asian | — | 0 | — | — | 0 | — | — | — | 0 |
| Native Hawaiian or Other Pacific Islander | — | 0 | — | — | 0 | — | — | — | 0 |
| Black or African American | — | 0 | — | — | 0 | — | — | — | 0 |
| White | — | 1 | — | — | 1 | — | — | — | 2 |
| More than one race | — | 0 | — | — | 0 | — | — | — | 0 |
| Unknown or Not Reported | — | 0 | — | — | 0 | — | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2022 to primary completion in May 2023, 11 months.
Results were first posted in Sep 2026, 3 years 3 months after primary completion.
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