Exploratory Clinical Investigation on Neurosensory Responses Via EEG Headband in Adults With Mild to Moderate Atopic Dermatitis After Application of Marketed Product Compared With Placebo (Water Application).

December 30, 2025 updated by: NovoBliss Research Pvt Ltd
This is a prospective, exploratory, double-blind, single-visit internal validation study designed to evaluate neurosensory responses using electroencephalography head band (EEG) in adult subjects with mild to moderate atopic dermatitis (AD) following a single topical application of marketed product compared with placebo (water application).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A total of twenty (20) subjects will be enrolled with ten in each arm, aged between 18 to 65 years, with mild to moderate AD for at least six months. Participants will be recruited after providing with the written subject information sheet, and eligibility will be determined based on predefined inclusion and exclusion criteria. The study consists of a single visit (Day 01), during which participants will undergo screening, randomization, enrolment, and baseline evaluations, followed by product application and post-application assessments up to 30 minutes, after which end-of-study procedures will be completed. Validation assessments will consist of EEG recordings to evaluate neurosensory responses in subjects with atopic dermatitis. The analysis will focus on changes in alpha, beta, and theta brainwave activity, which are key indicators of cortical processing related to sensory perception. In addition to EEG, digital photographs will be captured using a Nikon D3300 camera to document any visible skin changes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Sheetal Khandwala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age: 18 to 65 years (both inclusive) at the time of consent having mild to moderate atopic dermatitis. 2. Sex: Healthy male and non-pregnant/non-lactating females. 3. Females of childbearing potential must have a self-reported negative pregnancy test. 4. Subject are generally in good health. 5. Subjects who agree to come to the facility with clean and dry scalp and hair 6. Subjects with mild to moderate Atopic Dermatitis determined by Eczema

Area and Severity Index (EASI) score with moderate erythema (redness:

score 2) and mild scratch mark (scratching: score 1) will be enrolled into the study 7. Subjects are not allowed to participate in any other study until this study is complete. 8. Subjects willing and able to follow the study directions. 9. Having childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/ injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam,partner vasectomy or abstinence). Females will be considered as nonchildbearing potential if they are surgically sterile, have been postmenopausal for at least 1 year or have had a tubal ligation. 10. Subjects willing to give written consent through subject information sheet. 11. Subjects have not participated in a similar investigation in the past three months. 12. Subjects willing to use test product throughout the study period.

Exclusion Criteria:

  • History of any dermatological condition of the skin diseases. 2. Subject with present condition of allergic response to any cosmetic product. 3. Subjects with other dermatologic diseases besides AD whose presence or treatments could interfere with the assessment of disease (eg, Psoriasis). 4. Subjects who used systemic immunosuppressants within 4 weeks, topical steroids or immunomodulators within 1 week, moisturizers within 12 hours before evaluation. 5. History of alcohol or drug addiction. 6. The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances. 7. The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject. 8. Subjects having diabetes, hepatitis, epilepsy, thyroid or have or had any kind of cancer. 9. The subject must not have participated in a clinical study within 4 weeks prior to the screening visit of this study. 10. Any other condition which could warrant exclusion from the study, as per the dermatologist's/investigator's discretion. 11. Pregnant or breastfeeding or planning to become pregnant during the study period. 12. History of chronic illness which may influence the cutaneous state.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1 - Test Product- CeraVe Moisturizing Lotion
Arm 1 (Test Product): Subjects in this group will receive the marketed product, applied topically as per the study procedure.
Other: Marketed Test Product
Topical Application Frequency: Single Application. Spread the cream in the same direction and avoid scratching after application.
Experimental: Placebo Comparator: Arm 2
Arm 2 (Placebo Control): Subjects in this group will receive a placebo (water application), in which no active ingredient will be added. The placebo will be identical in appearance and texture to the test product to maintain blinding.
Other: Placebo
Topical Application Frequency : Single Application Spread the cream in the same direction and avoid scratching after application.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To measure neurosensory responses associated with pain, pruritus, and discomfort in subjects with atopic dermatitis.
Time Frame: • Baseline (before application of the test product) • During Stimulus Induction • Post-stimulus induction (test product use) at T-30 minutes.

To measure the changes in the

  • Alpha Wavelength activity
  • Beta Wavelength activity
  • Theta Wavelength activity It will be measured through MUSE Biosensing Headband. The headband will be applied over the subjects in head area and the electrodes will help in detection of the wavelength.
• Baseline (before application of the test product) • During Stimulus Induction • Post-stimulus induction (test product use) at T-30 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NovoBliss Research Pvt Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Nayan Patel, NovoBliss Research Private Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB250043-NB-V_1.0_16Oct25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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