Cleansing Device for the Treatment of Scalp and Hair Conditions

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.

Study Overview

• Status: Recruiting
• Conditions: Seborrheic Dermatitis; Dandruff; Hair Loss
• Intervention / Treatment: Device: Off-brand Waterpik®

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronda Farah, MD; Phone Number: (612)-625-8625; Email: dermresearch@umn.edu
• Study Contact Backup: Name: Maria Hordinsky, MD; Phone Number: (612)-625-8625; Email: dermresearch@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Ronda Farah, MD; Phone Number: 612-625-8625; Email: dermresearch@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Scalp and one treatment; Participants with healthy scalps who will receive one treatment 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.
Experimental: Healthy Scalp and three treatments; Participants with healthy scalps 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.
Experimental: Dandruff and one treatment; Participants with dandruff who will receive one treatment 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.
Experimental: Dandruff and three treatments; Participants with dandruff 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.
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: Seborrheic Dermatitis and three treatments; Participants with seborrheic dermatitis 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: March 31, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Scalp Dermatoses; Dermatitis; Dermatitis, Seborrheic; Dandruff
• Other Study ID Numbers: RFarah

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes