DandruffNCT07680608
Neurophysiological and Sleep-Related Effects of a Cosmetic Shampoo and Conditioner in Adults With Scalp Discomfort
An observational study of Dandruff, run by Zentrela Inc. at 1 site in Canada.
Trial summary
The goal of this clinical trial is to learn whether regular use of Nizoral® Daily Prevent shampoo and conditioner can improve scalp comfort, sleep experiences, mood, and overall well-being in adults who have scalp discomfort and difficulty sleeping. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dandruff
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2025to 7 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants were recruited from an existing volunteer database maintained by the research site in Hamilton, Ontario, Canada. The study population consisted of community-dwelling adults interested in participating in consumer product research. Recruitment was conducted through database outreach and screening questionnaires. Participants were selected from the local community and represented a range of ages and both sexes.
Who may be able to join
- Age 18 years or older.
- Reported at least one scalp symptom within the past 2 weeks, such as itching, dryness, sensitivity, redness, or flakes.
- Experienced scalp discomfort occasionally or more often during the past 2 weeks.
- Reported a scalp discomfort rating of 4 or higher on a 0-10 scale.
- Reported difficulty falling asleep or staying asleep within the past 2 weeks.
- Experienced sleep difficulty more than once per week.
Show all 10Show fewer
- Willing and able to use the study shampoo and conditioner at least 3 times per week during the study.
- Willing and able to wear a Fitbit sleep-tracking device during the study.
- Able to attend all scheduled study visits.
- Able to provide informed consent.
Who cannot join
- Current use of medicated scalp treatments or use within the previous 14 days.
- Known allergy or sensitivity to ingredients commonly found in shampoos or conditioners.
- Ongoing scalp conditions, including active psoriasis, eczema, or open sores.
- Use of sleep aids, sedatives, antihistamines, or other medications that affect sleep more than once per week during the previous 2 weeks.
- Participation in another clinical, cosmetic, or consumer research study within the previous 30 days.
- Any condition that, in the opinion of the investigators, could interfere with study participation, compliance with study procedures, or interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neurophysiological, Sleep-Related, and Mood Effects of a Cosmetic Shampoo and Conditioner Regimen in Adults With Scalp Discomfort and Sleep Difficulty: A Pilot EEG-Based Observational Study
The goal of this clinical trial is to learn whether regular use of Nizoral® Daily Prevent shampoo and conditioner can improve scalp comfort, sleep experiences, mood, and overall well-being in adults who have scalp discomfort and difficulty sleeping. The main questions it aims to answer are:
- Does using the shampoo and conditioner improve scalp comfort and reduce the impact of scalp discomfort on daily life?
- Does using the shampoo and conditioner improve sleep experiences and how rested participants feel?
- Does using the shampoo and conditioner affect mood and other measures of well-being?.
Read more
Participants completed a one-week period without hair products, followed by two weeks of using the study shampoo and conditioner at least three times per week. During the study, participants:
- Attended weekly study visits.
- Answered questions about their scalp comfort, sleep, and daily experiences.
- Wore a wrist-based sleep tracking device throughout the study. Completed weekly questionnaires about sleep and scalp health.
- Took part in non-invasive brain activity measurements during study visits.
Read the detailed description
This was a prospective, single-arm, observational study evaluating the effects of regular use of a cosmetic shampoo and conditioner on scalp comfort, sleep-related experiences, mood, and neurophysiological responses in adults reporting scalp discomfort and sleep difficulties.
Participants were recruited from an internal volunteer database and screened against predefined eligibility criteria. All participants provided written informed consent before any study procedures.
The study consisted of four weekly visits: a baseline visit (EEG, scalp and sleep questionnaires, initiation of Fitbit sleep monitoring), a washout visit one week later with no hair products, followed by two further visits assessing early and extended effects after approximately one and two weeks of product use, respectively. Daily sleep monitoring and weekly questionnaires continued throughout.
EEG recordings were analyzed using Cognalyzer® EEG-based metrics, including mood valence, relaxation, sleepiness, anger, and mental arousal. The primary objective was to evaluate changes in neurophysiological and self-reported measures of scalp comfort, sleep experiences, mood, and well-being following product use; exploratory objectives included sleep-related outcomes and EEG-derived indicators of emotional and cognitive state.
- Conditions
- Dandruff
- Being tested
- Cosmetic Shampoo and Conditioner Regimen
- Keywords
- dandruff, EEG, well-being, machine learning
- Medical subject headings
- Dandruff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic Shampoo and Conditioner RegimenOther
Participants used the study cosmetic shampoo together with the study cosmetic conditioner at least three times per week for two consecutive weeks, following a one-week washout period without hair products.
| Study group | Role | What they receive |
|---|---|---|
| Dandruff Group | Not described Receives: Other: Cosmetic Shampoo and Conditioner Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in EEG-Derived Mood Valence
EEG-derived mood valence, reflecting positive versus negative emotional state, compared between baseline visits (1-2) and product-use visits (3-4).
Measured: Up to 4 weeks
Secondary outcomes (6)
Change in EEG-Derived Relaxation Level
EEG-derived relaxation level compared between baseline and product-use visits.
Measured: Up to 4 weeks
Change in EEG-Derived Sleepiness Level
EEG-derived sleepiness indicators compared between baseline and product-use visits.
Measured: Up to 4 weeks
Change in EEG-Derived Anger Level
EEG-derived anger-related response compared between baseline and product-use visits.
Measured: Up to 4 weeks
Change in Self-Reported Scalp Comfort
Weekly questionnaire measures of scalp itch and discomfort compared between baseline and product-use periods.
Measured: Up to 4 weeks
Change in Self-Reported Sleep Quality
Weekly questionnaire measures of sleep onset, night-time waking, and feeling rested, compared between baseline and product-use periods.
Measured: Up to 4 weeks
Change in Fitbit-Measured Sleep Parameters
Wearable-derived sleep metrics collected nightly, compared between baseline and product-use periods.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start7 Nov 2025
- Primary completion7 Feb 2026
- Study completion7 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DandruffStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zentrela Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thornton & Ross
- Responsible party
- Sponsor
- Investigators
- Dan Bosnyak, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680608
- Sponsor's protocol ID
- CUSIC-74
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study, including electroencephalography (EEG), questionnaire, and wearable device data, will not be made available to other researchers. The study was conducted as a sponsor-supported consumer product research study, and there is no plan to share de-identified participant-level datasets or supporting data dictionaries outside the study team.
Publications
Bosnyak D, McDonald AC, Gasperin Haaz I, Qi W, Crowley DC, Guthrie N, Evans M. Use of a Novel EEG-Based Objective Test, the Cognalyzer(R), in Quantifying the Strength and Determining the Action Time of Cannabis Psychoactive Effects and Factors that May Influence Them Within an Observational Study Framework. Neurol Ther. 2022 Mar;11(1):51-72. doi: 10.1007/s40120-021-00293-w. Epub 2021 Nov 2.
PubMed 34727345McDonald AC, Gasperin Haaz I, Qi W, Crowley DC, Guthrie N, Evans M, Bosnyak D. Sensitivity, Specificity and Accuracy of a Novel EEG-Based Objective Test, the Cognalyzer(R), in Detecting Cannabis Psychoactive Effects. Adv Ther. 2021 May;38(5):2513-2531. doi: 10.1007/s12325-021-01718-6. Epub 2021 Apr 7.
PubMed 33826089
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological, Sleep-Related, and Mood Effects of a Cosmetic Shampoo and Conditioner Regimen in Adults With Scalp Discomfort and Sleep Difficulty: A Pilot EEG-Based Observational Study
- ClinicalTrials.gov ID
- NCT07680608
- Acronym / sponsor ID
- CUSIC-74
- Conditions
- Dandruff
- Keywords
- dandruff, EEG, well-being, machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Zentrela Inc.Industry (pharma, biotech, devices)
- Collaborators
- Thornton & Ross
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 7 Feb 2026 (actual)
- Study completion
- 7 Feb 2026 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether regular use of Nizoral® Daily Prevent shampoo and conditioner can improve scalp comfort, sleep experiences, mood, and overall well-being in adults who have scalp discomfort and difficulty sleeping. The main questions it aims to answer are:
- Does using the shampoo and conditioner improve scalp comfort and reduce the impact of scalp discomfort on daily life?
- Does using the shampoo and conditioner improve sleep experiences and how rested participants feel?
- Does using the shampoo and conditioner affect mood and other measures of well-being?.
Participants completed a one-week period without hair products, followed by two weeks of using the study shampoo and conditioner at least three times per week. During the study, participants:
- Attended weekly study visits.
- Answered questions about their scalp comfort, sleep, and daily experiences.
- Wore a wrist-based sleep tracking device throughout the study. Completed weekly questionnaires about sleep and scalp health.
- Took part in non-invasive brain activity measurements during study visits.
Detailed description
This was a prospective, single-arm, observational study evaluating the effects of regular use of a cosmetic shampoo and conditioner on scalp comfort, sleep-related experiences, mood, and neurophysiological responses in adults reporting scalp discomfort and sleep difficulties.
Participants were recruited from an internal volunteer database and screened against predefined eligibility criteria. All participants provided written informed consent before any study procedures.
The study consisted of four weekly visits: a baseline visit (EEG, scalp and sleep questionnaires, initiation of Fitbit sleep monitoring), a washout visit one week later with no hair products, followed by two further visits assessing early and extended effects after approximately one and two weeks of product use, respectively. Daily sleep monitoring and weekly questionnaires continued throughout.
EEG recordings were analyzed using Cognalyzer® EEG-based metrics, including mood valence, relaxation, sleepiness, anger, and mental arousal. The primary objective was to evaluate changes in neurophysiological and self-reported measures of scalp comfort, sleep experiences, mood, and well-being following product use; exploratory objectives included sleep-related outcomes and EEG-derived indicators of emotional and cognitive state.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dandruff Group | – | Other: Cosmetic Shampoo and Conditioner Regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited from an existing volunteer database maintained by the research site in Hamilton, Ontario, Canada. The study population consisted of community-dwelling adults interested in participating in consumer product research. Recruitment was conducted through database outreach and screening questionnaires. Participants were selected from the local community and represented a range of ages and both sexes.
Key inclusion criteria (10 listed)
- Age 18 years or older.
- Reported at least one scalp symptom within the past 2 weeks, such as itching, dryness, sensitivity, redness, or flakes.
- Experienced scalp discomfort occasionally or more often during the past 2 weeks.
- Reported a scalp discomfort rating of 4 or higher on a 0-10 scale.
- Reported difficulty falling asleep or staying asleep within the past 2 weeks.
Key exclusion criteria (6 listed)
- Current use of medicated scalp treatments or use within the previous 14 days.
- Known allergy or sensitivity to ingredients commonly found in shampoos or conditioners.
- Ongoing scalp conditions, including active psoriasis, eczema, or open sores.
- Use of sleep aids, sedatives, antihistamines, or other medications that affect sleep more than once per week during the previous 2 weeks.
- Participation in another clinical, cosmetic, or consumer research study within the previous 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cosmetic Shampoo and Conditioner RegimenParticipants used the study cosmetic shampoo together with the study cosmetic conditioner at least three times per week for two consecutive weeks, following a one-week washout period without hair products. | Other | Dandruff Group |
Primary outcome
Change in EEG-Derived Mood Valence
Time frame: Up to 4 weeks
EEG-derived mood valence, reflecting positive versus negative emotional state, compared between baseline visits (1-2) and product-use visits (3-4).
6 secondary outcomes
Change in EEG-Derived Relaxation Level
Time frame: Up to 4 weeks
Change in EEG-Derived Sleepiness Level
Time frame: Up to 4 weeks
Change in EEG-Derived Anger Level
Time frame: Up to 4 weeks
Change in Self-Reported Scalp Comfort
Time frame: Up to 4 weeks
Change in Self-Reported Sleep Quality
Time frame: Up to 4 weeks
Change in Fitbit-Measured Sleep Parameters
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 34727345Bosnyak D, McDonald AC, Gasperin Haaz I, Qi W, Crowley DC, Guthrie N, Evans M. Use of a Novel EEG-Based Objective Test, the Cognalyzer(R), in Quantifying the Strength and Determining the Action Time of Cannabis Psychoactive Effects and Factors that May Influence Them Within an Observational Study Framework. Neurol Ther. 2022 Mar;11(1):51-72. doi: 10.1007/s40120-021-00293-w. Epub 2021 Nov 2.
- Background: PubMed 33826089McDonald AC, Gasperin Haaz I, Qi W, Crowley DC, Guthrie N, Evans M, Bosnyak D. Sensitivity, Specificity and Accuracy of a Novel EEG-Based Objective Test, the Cognalyzer(R), in Detecting Cannabis Psychoactive Effects. Adv Ther. 2021 May;38(5):2513-2531. doi: 10.1007/s12325-021-01718-6. Epub 2021 Apr 7.
- Individual participant dataSharing planned: No. Individual participant data collected during this study, including electroencephalography (EEG), questionnaire, and wearable device data, will not be made available to other researchers. The study was conducted as a sponsor-supported consumer product research study, and there is no plan to share de-identified participant-level datasets or supporting data dictionaries outside the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Bosnyak, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dandruff, run by Zentrela Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in EEG-Derived Mood Valence (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07680608, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.