NCT07333300

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).

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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.

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
OTHER	Marketed Test Product	Topical Application Frequency: Single Application. Spread the cream in the same direction and avoid scratching after application.
OTHER	Placebo	Topical Application Frequency : Single Application Spread the cream in the same direction and avoid scratching after application.

Timeline

• Start date: 2026-01-04
• Primary completion: 2026-01-05
• Completion: 2026-01-06
• First posted: 2026-01-12
• Last updated: 2026-01-12