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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
No Placebo-Only Group
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.
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.
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 belowSelect...
I am currently practicing sexual abstinence.
Select...
I use birth control that contains only progestogen.
Select...
I am using a combined hormonal birth control method.
Select...
My partner has had a vasectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Adherent Scalp Flaking Scale (ASFS)
Secondary study objectives
Change in Erythema Score
Change in Patient Sensory Assessment of Scalp & Hair Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,434 Previous Clinical Trials
1,621,662 Total Patients Enrolled
Maria Hordinsky, MDPrincipal InvestigatorUniversity of Minnesota Medical School Department of Dermatology
16 Previous Clinical Trials
379 Total Patients Enrolled
Ronda Farah, MDPrincipal InvestigatorUniversity of Minnesota Medical School Department of Dermatology
2 Previous Clinical Trials
21 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are using a hormone-releasing intrauterine device.I am currently practicing sexual abstinence.I use birth control that contains only progestogen.I have been diagnosed with a scalp condition by a dermatologist.Criterion: The WaterPik device uses ultrasound technology, and it's not recommended for pregnant women.I am using a combined hormonal birth control method.You have an intrauterine device (IUD).You are currently using an intrauterine hormone-releasing system.My partner has had a vasectomy.
Research Study Groups:
This trial has the following groups:- Group 1: Dandruff and one treatment
- Group 2: Dandruff and three treatments
- Group 3: Seborrheic Dermatitis with one treatment
- Group 4: Seborrheic Dermatitis and three treatments
- Group 5: Hair loss disease and three treatments
- Group 6: Healthy Scalp and one treatment
- Group 7: Healthy Scalp and three treatments
- Group 8: Hair loss disease and one treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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