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.
Conditions:
🦠 Dandruff 🦠 Seborrheic Dermatitis 🦠 Hair Loss
🗓️ Study Start (Actual) 30 June 2022
🗓️ Primary Completion (Estimated) July 2024
✅ Study Completion (Estimated) July 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Minneapolis, Minnesota, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 31 March 2022
  • First Submitted that Met QC Criteria 31 March 2022
  • First Posted 8 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 August 2023
  • Last Update Posted 18 August 2023
  • Last Verified August 2023