Exploratory Clinical Investigation on Neurosensory Responses Via EEG Headband in Adults With Mild… (NCT07333300) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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).
20 participantsStarted 2026-01-04
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
Exclu…
What they're measuring
1
To measure neurosensory responses associated with pain, pruritus, and discomfort in subjects with atopic dermatitis.
Timeframe: • Baseline (before application of the test product) • During Stimulus Induction • Post-stimulus induction (test product use) at T-30 minutes.