Neurophysiological and Sleep-Related Effects of a Cosmetic Shampoo and Conditioner in Adults With Scalp Discomfort

NCT07680608 | Completed

• 1 other identifier: CUSIC-74
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does using the shampoo and conditioner improve scalp comfort and reduce the impact of scalp discomfort on daily life?
2. 2.Does using the shampoo and conditioner improve sleep experiences and how rested participants feel?
3. 3.Does using the shampoo and conditioner affect mood and other measures of well-being?.
4. 4.Attended weekly study visits.
5. 5.Answered questions about their scalp comfort, sleep, and daily experiences.
6. 6.Wore a wrist-based sleep tracking device throughout the study. Completed weekly questionnaires about sleep and scalp health.
7. 7.Took part in non-invasive brain activity measurements during study visits.

Conditions

Dandruff

Keywords

dandruff; EEG; well-being; machine learning

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in EEG-Derived Relaxation Level

  Up to 4 weeks

• Change in EEG-Derived Sleepiness Level

  Up to 4 weeks

• Change in EEG-Derived Anger Level

  Up to 4 weeks

• Change in Self-Reported Scalp Comfort

  Up to 4 weeks

• Change in Self-Reported Sleep Quality

  Up to 4 weeks

Study Arms (1)

Dandruff Group

Other: Cosmetic Shampoo and Conditioner Regimen

Interventions

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.

Dandruff Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zentrela Inc.: lead
• Thornton & Ross: collaborator

Study Sites (1)

Zentrela Inc.

Hamilton, Ontario, L8P 1J4, Canada

Location

Related Publications (2)

• 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.

  PMID: 34727345 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.

  PMID: 33826089 BACKGROUND

MeSH Terms

Conditions

Dandruff

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Scalp Dermatoses

Study Officials

• Dan Bosnyak, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 2, 2026
• Study Start: November 7, 2025
• Primary Completion: February 7, 2026
• Study Completion: February 7, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)