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Cleansing Device for the Treatment of Scalp and Hair Conditions

Primary Purpose

Dandruff, Seborrheic Dermatitis, Hair Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Off-brand Waterpik®
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dandruff

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 31, 2022
Last Updated
August 16, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05319444
Brief Title
Cleansing Device for the Treatment of Scalp and Hair Conditions
Official Title
Cleansing Device for the Treatment of Scalp and Hair Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dandruff, Seborrheic Dermatitis, Hair Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Scalp and one treatment
Arm Type
Experimental
Arm Description
Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up.
Arm Title
Healthy Scalp and three treatments
Arm Type
Experimental
Arm Description
Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up.
Arm Title
Dandruff and one treatment
Arm Type
Experimental
Arm Description
Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up.
Arm Title
Dandruff and three treatments
Arm Type
Experimental
Arm Description
Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up.
Arm Title
Hair loss disease and one treatment
Arm Type
Experimental
Arm Description
Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up.
Arm Title
Seborrheic Dermatitis with one treatment
Arm Type
Experimental
Arm Description
Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up.
Arm Title
Seborrheic Dermatitis and three treatments
Arm Type
Experimental
Arm Description
Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up.
Arm Title
Hair loss disease and three treatments
Arm Type
Experimental
Arm Description
Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up.
Intervention Type
Device
Intervention Name(s)
Off-brand Waterpik®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Adherent Scalp Flaking Scale (ASFS)
Description
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
Secondary Outcome Measure Information:
Title
Change in Erythema Score
Description
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
Title
Change in Patient Sensory Assessment of Scalp & Hair Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronda Farah, MD
Phone
(612)-625-8625
Email
dermresearch@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Hordinsky, MD
Phone
(612)-625-8625
Email
dermresearch@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronda Farah, MD
Organizational Affiliation
University of Minnesota Medical School Department of Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota Medical School Department of Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronda Farah, MD
Phone
612-625-8625
Email
dermresearch@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Cleansing Device for the Treatment of Scalp and Hair Conditions

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