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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Test Product | Other | Topical Application Frequency: Single Application. Spread the cream in the same direction and avoid scratching after application. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure neurosensory responses associated with pain, pruritus, and discomfort in subjects with atopic dermatitis. | To measure the changes in the
| • Baseline (before application of the test product) • During Stimulus Induction • Post-stimulus induction (test product use) at T-30 minutes. |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maheshvari N Patel | Contact | 09909013236 | maheshvari@novobliss.in | |
| Sheetal Khandwala | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Nayan Patel | NovoBliss Research Private Limited | Study Director |
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| Placebo | Other | Topical Application Frequency : Single Application Spread the cream in the same direction and avoid scratching after application. |
|
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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