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Cleansing Device for Scalp Conditions

N/A
Recruiting
Led By Maria Hordinsky, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexual abstinence
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will test whether an investigational WaterPik and brush device can improve scalp health.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from the device's pressure or ultrasound technology on sensitive scalps but specific side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently practicing sexual abstinence.
Select...
I use birth control that contains only progestogen.
Select...
I have been diagnosed with a scalp condition by a dermatologist.
Select...
I am using a combined hormonal birth control method.
Select...
My partner has had a vasectomy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Adherent Scalp Flaking Scale (ASFS)
Secondary outcome measures
Change in Erythema Score
Change in Patient Sensory Assessment of Scalp & Hair Score

Trial Design

8Treatment groups
Experimental Treatment
Group I: Seborrheic Dermatitis with one treatmentExperimental Treatment1 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 treatmentsExperimental Treatment1 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 treatmentsExperimental Treatment1 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 treatmentExperimental Treatment1 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 treatmentsExperimental Treatment1 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 treatmentExperimental Treatment1 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 treatmentsExperimental Treatment1 Intervention
Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up.
Group VIII: Dandruff and one treatmentExperimental Treatment1 Intervention
Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up.

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,378 Previous Clinical Trials
1,588,469 Total Patients Enrolled
Maria Hordinsky, MDPrincipal InvestigatorUniversity of Minnesota Medical School Department of Dermatology
16 Previous Clinical Trials
418 Total Patients Enrolled
Ronda Farah, MDPrincipal InvestigatorUniversity of Minnesota Medical School Department of Dermatology
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Off-brand Waterpik® (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05319444 — N/A
Seborrheic Dermatitis Research Study Groups: Dandruff and one treatment, Dandruff and three treatments, Seborrheic Dermatitis with one treatment, Seborrheic Dermatitis and three treatments, Hair loss disease and three treatments, Healthy Scalp and one treatment, Healthy Scalp and three treatments, Hair loss disease and one treatment
Seborrheic Dermatitis Clinical Trial 2023: Off-brand Waterpik® Highlights & Side Effects. Trial Name: NCT05319444 — N/A
Off-brand Waterpik® (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05319444 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research currently recruiting participants?

"According to the records on clinicaltrials.gov, enrollment for this research project is still in progress. Its first public appearance was June 30th 2022 and it has since been updated on August 11th of that same year."

Answered by AI

How many participants is this research endeavor admitting?

"Affirmative. Clinicaltrials.gov displays that the recruitment process for this research endeavour is ongoing, having been posted on June 30th 2022 and updated as recently as August 11th of the same year. This clinical trial needs 40 subjects from 1 centre to complete its data collection phase."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have had hair loss and I have tried vitamins and topical items and it hasn’t worked.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Cleansing Device for the Treatment of Scalp and Hair Conditions
2022. "Cleansing Device for the Treatment of Scalp and Hair Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05319444.
All > Androgenetic Alopecia > Alopecia
~3 spots leftby Jul 2024
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