Atopic Dermatitis (AD)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).
A study testing Marketed Test Product in people with Atopic Dermatitis (AD), run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- Marketed Test Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 14 Nov 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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)
- Being tested
- Marketed Test Product, Placebo
- Keywords
- atopic dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marketed Test ProductOther
Topical Application Frequency: Single Application. Spread the cream in the same direction and avoid scratching after application.
PlaceboOther
Topical Application Frequency : Single Application Spread the cream in the same direction and avoid scratching after application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: • Baseline (before application of the test product) • During Stimulus Induction • Post-stimulus induction (test product use) at T-30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start14 Nov 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nayan Patel, Study director, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333300
- Sponsor's protocol ID
- NB250043-NB-V_1.0_16Oct25
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT07333300
- Acronym / sponsor ID
- NB250043-NB-V_1.0_16Oct25
- Conditions
- Atopic Dermatitis (AD)
- Keywords
- atopic dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Test Product- CeraVe Moisturizing Lotion | Experimental | Other: Marketed Test ProductArm 1 (Test Product): Subjects in this group will receive the marketed product, applied topically as per the study procedure. |
| Placebo Comparator: Arm 2 | Experimental | Other: PlaceboArm 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marketed Test ProductTopical Application Frequency: Single Application. Spread the cream in the same direction and avoid scratching after application. | Other | Arm 1 - Test Product- CeraVe Moisturizing Lotion |
| PlaceboTopical Application Frequency : Single Application Spread the cream in the same direction and avoid scratching after application. | Other | Placebo Comparator: Arm 2 |
Primary outcome
To measure neurosensory responses associated with pain, pruritus, and discomfort in subjects with atopic dermatitis.
Time frame: • Baseline (before application of the test product) • During Stimulus Induction • Post-stimulus induction (test product use) at T-30 minutes.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayan Patel study director
NovoBliss Research Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marketed Test Product in people with Atopic Dermatitis (AD), run by NovoBliss Research Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure neurosensory responses associated with pain, pruritus, and discomfort in subjects with atopic dermatitis. (time frame: • Baseline (before application of the test product) • During Stimulus Induction • Post-stimulus induction (test product use) at T-30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.