Cleansing Device for Scalp Conditions

Overseen By Ronda Farah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Non-English speaking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a WaterPik and brush device (a cleansing device) can improve scalp health. It targets individuals with various scalp conditions, such as dandruff, seborrheic dermatitis (which causes scaly patches and red skin), or hair loss, as well as those with healthy scalps. Participants will be divided into groups to receive either one or three treatments. Individuals with frequent dandruff, constant scalp itchiness from seborrheic dermatitis, or ongoing hair loss may be well-suited for this study. As an unphased trial, this study offers a unique opportunity to explore new methods for improving scalp health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this cleansing device is safe for scalp conditions?

Research has shown that the Waterpik device is safe, particularly for dental care. The FDA has approved it for cleaning teeth, indicating it is generally well-tolerated. However, this trial tests a version of the device for scalp care, which is not its usual application.

Some reports mention the device's hose breaking, but this does not affect its safety when used on the scalp. Overall, the device's safety record in other uses is reassuring, but its use for scalp treatment remains under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the off-brand Waterpik® scalp cleansing device because it offers a novel approach to treating scalp conditions like dandruff, seborrheic dermatitis, and hair loss. Unlike traditional treatments that often involve medicated shampoos or topical creams, this device uses a targeted water jet to cleanse the scalp directly, which could enhance scalp health by removing debris, excess oil, and buildup. This method is non-invasive and could be more comfortable for users, potentially improving adherence and outcomes. The device's ability to deliver consistent, gentle cleansing might offer faster relief and be a game-changer for those seeking alternative scalp health solutions.

What evidence suggests that this device is effective for improving scalp health?

Research has shown that the Waterpik device effectively removes particles and debris. Dental studies found it removes plaque better than traditional flossing, though not as well as some other methods. The device uses a stream of water to clean, which may also help with dandruff and other scalp issues by breaking up and washing them away. Primarily used for dental care, this cleaning power could also enhance scalp health by massaging and cleansing. This trial will explore its potential benefits for various scalp conditions, including dandruff and seborrheic dermatitis, by testing different treatment frequencies and conditions. ^{1 5 6 7 8}

Who Is on the Research Team?

Maria K Hordinsky

Principal Investigator

University of Minnesota Medical School Department of Dermatology

Ronda Farah, MD

Principal Investigator

University of Minnesota Medical School Department of Dermatology

Are You a Good Fit for This Trial?

This trial is for individuals with scalp conditions like eczema, dandruff, or hair loss. Participants must be evaluated by a dermatologist and use two forms of contraception if they are women who can have children. Non-English speakers, pregnant or lactating women, and those planning pregnancy during the study cannot join.

Inclusion Criteria

You are using a hormone-releasing intrauterine device.

I am currently practicing sexual abstinence.

I use birth control that contains only progestogen.

Exclusion Criteria

Current clinical condition that, in the opinion of the site investigator, would interfere with adherence to study requirements

Exclusion related to pregnancy, lactation, or plans to become pregnant over the course of the study (based on self-report from the participant)

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or three treatments with the investigational WaterPik and brush device

4 weeks

1-3 visits (in-person)

Follow-up

Participants are monitored for changes in erythema, scalp flaking, and sensory assessment scores

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Off-brand Waterpik®

Trial Overview The trial tests an off-brand Waterpik device that uses ultrasonic technology to massage and cleanse the scalp. It aims to see if this improves scalp health in people with various scalp conditions.

How Is the Trial Designed?

Group I: Seborrheic Dermatitis with one treatment Experimental Treatment 1 Intervention

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

Group II: Seborrheic Dermatitis and three treatments Experimental Treatment 1 Intervention

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

Group III: Healthy Scalp and three treatments Experimental Treatment 1 Intervention

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

Group IV: Healthy Scalp and one treatment Experimental Treatment 1 Intervention

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

Group V: Hair loss disease and three treatments Experimental Treatment 1 Intervention

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

Group VI: Hair loss disease and one treatment Experimental Treatment 1 Intervention

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

Group VII: Dandruff and three treatments Experimental Treatment 1 Intervention

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

Group VIII: Dandruff and one treatment Experimental Treatment 1 Intervention

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

Off-brand Waterpik® is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Waterpik for:

• Oral hygiene
• Gingivitis prevention
• Plaque removal

Approved in European Union as Waterpik for:

• Oral hygiene
• Gingivitis prevention
• Plaque removal

Approved in Canada as Waterpik for:

• Oral hygiene
• Gingivitis prevention
• Plaque removal

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

The Braun Oral-B OxyJet Oral Irrigator, when used alongside manual brushing, is safe and effectively reduces plaque and improves gingival health in individuals with mild-to-moderate gingivitis, as shown in an 8-week study with 64 participants.

Significant reductions in plaque and gingival inflammation were observed at various points during the study, although the differences between the irrigator group and the manual brushing-only group did not always reach statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, clinical evaluation of the safety and efficacy of a novel oral irrigator. Frascella, JA., Fernández, P., Gilbert, RD., et al.[2010]

The dental water jet, developed in the late 1950s, has been extensively studied for its effectiveness in improving oral health, particularly with the Waterpik model being the most researched.

This article aims to equip dental professionals with evidence-based insights on the benefits and expected outcomes of using dental water jets, helping them make informed decisions for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dental water jet: a product ahead of its time. Ciancio, SG.[2022]

In a study involving 45 volunteers with gingivitis, the use of an oral irrigator with a subgingival tip did not show any significant clinical benefits in reducing gingivitis compared to standard oral hygiene education alone over a 3-month period.

All groups, including those using the irrigator and those using an herbal mouth rinse, experienced improvements in plaque and gingival indices, but there were no statistically significant differences between the groups, indicating that professional oral care education was the key factor in improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does professional preventive care benefit from additional subgingival irrigation? Ernst, CP., Pittrof, M., Fürstenfelder, S., et al.[2018]

Water flossers have been proven safe and effective for over 50 years, positively impacting oral health by reducing plaque, bleeding, and gingivitis.

Extensive research has shown that water flossers do not harm the attachment of gum tissue or pocket depth, countering claims of potential negative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of a water flosser: a literature review. Jolkovsky, DL., Lyle, DM.[2016]

In a study involving 38 patients, both mechanical brushing and oral irrigation significantly reduced biofilm and improved oral tissue health, as indicated by lower plaque and gingival indices, probing depth, and bleeding on probing.

There was no significant difference in effectiveness or patient satisfaction between mechanical brushing and oral irrigation, suggesting that both methods are equally effective for maintaining oral hygiene in patients with implant-supported prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Brushing Associated With Oral Irrigation in Maintenance of Peri-Implant Tissues and Overdentures: Clinical Parameters and Patient Satisfaction. Salles, MM., de Cássia Oliveira, V., Macedo, AP., et al.[2021]

In a study involving 35 participants, a novel oral water irrigator removed about 40.7% of plaque, which is significantly less effective than the 71.6% removal achieved by a conventional electric toothbrush.

However, the oral irrigator caused fewer gingival abrasions compared to the electric toothbrush, suggesting it may be a safer option for maintaining gum health while cleaning teeth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plaque removing capacity of a novel high pressure water irrigator. Eberhard, J., Damm, S., Freitag, S., et al.[2010]

In a study of 90 participants with gingivitis, using an oral irrigator (WaterPik®) alongside a toothbrush significantly reduced gingival inflammation and dental plaque compared to using a toothbrush alone, with improvements noted at 4, 8, and 12 weeks.

The oral irrigator was found to be safe, with no significant adverse effects reported, although some transient gingival bleeding was observed; overall, self-reported pain and sensitivity were similar between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Oral Irrigator on the Control of Dental Plaque and Gingivitis: A Randomized, Single-Blind, Parallel-Group Clinical Trial. Ren, X., He, J., Cheng, R., et al.[2023]

The HydraBrush Oral Health System (OHS) was found to be more effective than rinsing alone with a powered toothbrush in delivering a solution to the bottom of 5-6 mm periodontal pockets, as shown by a significant visual increase in solution presence (p=0.0001).

Both the OHS and the Sonicare Elite 7800 toothbrush were safe and well-accepted by patients, indicating that the new device could be a beneficial tool for improving oral health without compromising patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Penetration of fluids into periodontal pockets using a powered toothbrush/irrigator device. Brackett, MG., Drisko, CL., Thompson, AL., et al.[2013]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05319444/cleansing-device-for-the-treatment-of-scalp-and-hair-conditions

Cleansing Device for the Treatment of Scalp and Hair ... The objective of this study is to evaluate an improvement of scalp health after the use of an investigational off-label WaterPik and brush ...

2. withpower.com withpower.com/trial/cleansing-device-for-scalp-conditions-23859

Cleansing Device for Scalp Conditions In a study involving 35 participants, a novel oral water irrigator removed about 40.7% of plaque, which is significantly less effective than the 71.6% removal ...

3. clinicaltrial.be clinicaltrial.be/en/details/30026?only_active=0&only_eligible=0&only_recruiting=0&per_page=100

Cleansing Device for the Treatment of Scalp and Hair Cond... Waterpik® was FDA approved in 2018 to provide pressured water combined with a powered toothbrush for optimal plaque and particle removal when ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10906797/

Comparing the effectiveness of water flosser and dental ... Results: The majority of the studies favored water flossers over dental floss in plaque reduction. Water flosser was also found to be effective in removing ...

5. waterpik.com waterpik.com/pro/clinical-research/waterpik-clinical-research-abstracts.pdf

Waterpik™ Clinical Research Summary For bleeding, the Waterpik™ dental water jet was 87% more effective at reducing gingival bleeding. Conclusion. Patients who used the Waterpik™ dental water jet ...

6. waterpik.com.au waterpik.com.au/clinical-research-results/waterpik-water-flosser-unequivocally-proven-safe-in-clinical-studies-over-5-decades/

Unequivocally Proven Safe in Clinical Studies Over 5 ... The Waterpik Water Flosser has been proven safe. Findings from Clinical Studies on the Safety of the Waterpik Water Flosser. Histological reduction in ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4825156

MAUDE Adverse Event Report: WATER PIK, INC. WATERPIK ... Inspection of returned unit showed that the irrigator hose was broken below the handle.The hose material was brittle and could easily be broken in the area ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05319444?term=AREA%5BConditionSearch%5D(%22Dandruff%22)&rank=8

Cleansing Device for the Treatment of Scalp and Hair ... 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 ...