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Cleansing Device for the Treatment of Scalp and Hair Conditions

NCT05319444 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ronda Farah, MD · University of Minnesota Medical School Department of Dermatology

  • Maria Hordinsky, MD · University of Minnesota Medical School Department of Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319444 on ClinicalTrials.gov