Trial Outcomes & Findings for Cleansing Device for the Treatment of Scalp and Hair Conditions (NCT NCT05319444)

NCT ID: NCT05319444

Last Updated: 2026-09-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

4 weeks

Results posted on

2026-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Scalp and Three Treatments Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up. 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.	Hair Loss Disease and One Treatment Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up. 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.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Healthy Scalp and One Treatment Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up. 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.	Healthy Scalp and Three Treatments Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up. 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.	Dandruff and One Treatment Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up. 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.	Dandruff and Three Treatments Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up. 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.	Hair Loss Disease and One Treatment Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up. 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.	Seborrheic Dermatitis With One Treatment Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up. 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.	Seborrheic Dermatitis and Three Treatments Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up. 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.	Hair Loss Disease and Three Treatments Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up. 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.
Overall Study Study abandoned	0	1	0	0	1	0	0	0

Baseline Characteristics

Cleansing Device for the Treatment of Scalp and Hair Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Scalp and One Treatment Participants with healthy scalps who will receive one treatment with the device and complete one in-person follow-up. 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.	Healthy Scalp and Three Treatments n=1 Participants Participants with healthy scalps who will receive three treatments with the device and complete one in-person follow-up. 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.	Dandruff and One Treatment Participants with dandruff who will receive one treatment with the device and complete one in-person follow-up. 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.	Dandruff and Three Treatments Participants with dandruff who will receive three treatments with the device and complete one in-person follow-up. 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.	Hair Loss Disease and One Treatment n=1 Participants Participants with hair loss disease who will receive one treatment with the device and complete one in-person follow-up. 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.	Seborrheic Dermatitis With One Treatment Participants with seborrheic dermatitis disease who will receive one treatment with the device and complete one in-person follow-up. 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.	Seborrheic Dermatitis and Three Treatments Participants with seborrheic dermatitis who will receive three treatments with the device and complete one in-person follow-up. 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.	Hair Loss Disease and Three Treatments Participants with hair loss disease who will receive three treatments with the device and complete one in-person follow-up. 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.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	1 Participants n=23 Participants	—	—	1 Participants n=24 Participants	—	—	—	2 Participants n=4 Participants
Age, Categorical >=65 years	—	0 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	0 Participants n=4 Participants
Sex: Female, Male Female	—	0 Participants n=23 Participants	—	—	1 Participants n=24 Participants	—	—	—	1 Participants n=4 Participants
Sex: Female, Male Male	—	1 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Asian	—	0 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	—	0 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	0 Participants n=4 Participants
Race (NIH/OMB) White	—	1 Participants n=23 Participants	—	—	1 Participants n=24 Participants	—	—	—	2 Participants n=4 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=23 Participants	—	—	0 Participants n=24 Participants	—	—	—	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: This outcome was not collected or analyzed because the study was abandoned before these outcome data could be obtained. Therefore, no data are available to report for these outcomes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: This outcome was not collected or analyzed because the study was abandoned before these outcome data could be obtained. Therefore, no data are available to report for these outcomes.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

Population: This outcome was not collected or analyzed because the study was abandoned before these outcome data could be obtained. Therefore, no data are available to report for these outcomes.

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.