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).

NCT07333300 | Not Yet Recruiting

• 1 other identifier: NB250043-NB-V_1.0_16Oct25
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Atopic Dermatitis (AD)

Keywords

atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• To measure neurosensory responses associated with pain, pruritus, and discomfort in subjects with atopic dermatitis.

  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.

Study Arms (2)

Arm 1 - Test Product- CeraVe Moisturizing Lotion

EXPERIMENTAL

Arm 1 (Test Product): Subjects in this group will receive the marketed product, applied topically as per the study procedure.

Other: Marketed Test Product

Placebo Comparator: Arm 2

EXPERIMENTAL

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

Interventions

Marketed Test Product OTHER

Topical Application Frequency: Single Application. Spread the cream in the same direction and avoid scratching after application.

Arm 1 - Test Product- CeraVe Moisturizing Lotion

Placebo OTHER

Topical Application Frequency : Single Application Spread the cream in the same direction and avoid scratching after application.

Placebo Comparator: Arm 2

Eligibility Criteria

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

You may qualify if:

• 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.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Nayan Patel

  NovoBliss Research Private Limited

  STUDY DIRECTOR

Central Study Contacts

Maheshvari N Patel

CONTACT

09909013236; maheshvari@novobliss.in

Sheetal Khandwala

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: January 12, 2026
• Study Start: January 4, 2026
• Primary Completion: January 5, 2026
• Study Completion: January 6, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share