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| Name | Class |
|---|---|
| Thornton & Ross | UNKNOWN |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dandruff Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic Shampoo and Conditioner Regimen | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in EEG-Derived Relaxation Level | EEG-derived relaxation level compared between baseline and product-use visits. | Up to 4 weeks |
| Change in EEG-Derived Sleepiness Level | EEG-derived sleepiness indicators compared between baseline and product-use visits. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Bosnyak, PhD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrela Inc. | Hamilton | Ontario | L8P 1J4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34727345 | Background | 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. | |
| 33826089 |
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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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| ID | Term |
|---|---|
| D063807 | Dandruff |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012536 | Scalp Dermatoses |
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| Up to 4 weeks |
| Change in EEG-Derived Anger Level | EEG-derived anger-related response compared between baseline and product-use visits. | 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. | 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. | Up to 4 weeks |
| Change in Fitbit-Measured Sleep Parameters | Wearable-derived sleep metrics collected nightly, compared between baseline and product-use periods. | Up to 4 weeks |
| Background |
| McDonald 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. |