| CTRI Number |
CTRI/2025/11/097424 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Validation Study ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Exploratory study evaluating neurosensory responses. |
|
Scientific Title of Study
|
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 Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250043-NB-V _1.0 16 Oct 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Pvt Ltd |
| Address |
NovoBliss Research Pvt Ltd
313 Silver Radiance 4, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Pvt Ltd |
| Address |
NovoBliss Research Pvt Ltd
313 Silver Radiance 4, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Pvt Ltd |
| Address |
NovoBliss Research Pvt Ltd
313 Silver Radiance 4, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| NovoBliss Research Private Limited. 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Pvt Ltd |
NovoBliss Research Pvt. Ltd.
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Clinical Trail Department.
Ahmadabad
GUJARAT |
07948983895
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS - Independent ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Product |
Topical Application
Frequency: Single Application
Spread the cream in the same direction and avoid scratching after application. |
| Intervention |
Marketed Test Product |
Topical Application
Frequency: Single Application
Spread the cream in the same direction and avoid scratching after application. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) 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 non-childbearing potential if they are surgically sterile, have been post-menopausal 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.
|
|
| ExclusionCriteria |
| Details |
1) 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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate neurosensory responses associated with pain, pruritus, and discomfort in subjects with atopic dermatitis, by comparing EEG activity at baseline and after application of the test products, as well as between the active product and placebo groups. The objective will specifically assess changes in alpha, beta, and theta brainwave activity.
|
The primary endpoint will be the change in neurosensory responses related to pain and discomfort in subjects with atopic dermatitis, measured through EEG recordings (Muse® EEG headband) at three time points:
Baseline (before application)
Post-stimulus induction
30 minutes after product application
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief 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). 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, if any. |