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).

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovoBliss Research Pvt Ltd

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Marketed Test Product

    Other intervention

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

  • Placebo

    Other intervention

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Arm 1 - Test Product- CeraVe Moisturizing LotionExperimental treatment 1 intervention
Group B: Placebo Comparator: Arm 2Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
• Baseline (before application of the test product) • During Stimulus Induction • Post-stimulus induction (test product use) at T-30 minutes.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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