| CTRI Number |
CTRI/2026/02/103891 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Clinical Safety and Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Consumer and Eye Irritation Study |
|
Scientific Title of Study
|
A Consumer Insight Study with Instrument-Based Efficacy Assessments and Ocular Irritation (Eye Instillation) Evaluation of a Hydrating Cleanser Without Active Ingredients for Removal of Sunscreen and Everyday Makeup in Healthy Adult Male and Female Participants. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB260007-RV, 1.0, 7 Feb 26 |
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 Private Limited
313 Silver Radiance 4, Gota
Ahmadabad
GUJARAT
32481
India |
| Phone |
07948983895 |
| 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 Private Limited
313 Silver Radiance 4, Gota
GUJARAT
32481
India |
| Phone |
07948983895 |
| 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 Private Limited
313 Silver Radiance 4, Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Relaner Ventures Pvt. Ltd.
412, The Capital 2, Science City Road, Sola,
Ahmedabad, Gujarat - 380060, India
|
|
|
Primary Sponsor
|
| Name |
Relaner Ventures Pvt. Ltd |
| Address |
412, The Capital 2, Science City Road, Sola,
Ahmedabad, Gujarat - 380060, India
|
| Type of Sponsor |
Other [Manufacturer of cosmetics and toileteries] |
|
|
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 |
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, 32481, India
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 |
Healthy Human with Normal Skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eltior Skin-Reset Cleanser |
Marketed By: Relaner Ventures Pvt. Ltd.
Route of Application: Topical
Mode of Usage: Participants will be instructed to wet the face with water and dispense an adequate amount of the cleanser onto their palms. Then it will be gently massaged onto the face in circular motions for approximately 30–60 seconds, ensuring even coverage while avoiding the eye area. The cleanser will then be thoroughly rinsed off with water, and the face will be gently patted dry using a clean towel.
Frequency: Once a day
Storage temperature: Store at room temperature 20°C to 30°C, away from sunlight
Application Site: Face |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Ages 18-55 years both inclusive.
2) Males and non-pregnant/non-lactating females
3) Females with self-reported negative pregnancy test
4) Having general good health and has both eyes.
5) Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
6) Pass an eye sting evaluation using isotonic saline.
7) Willing to refrain from using any eye drops on the day of the study.
8) In general, good health as determined by the Investigator on the basis of medical history.
9) Willig and able to follow the study protocol to participate in the study.
10) Able to understand and provide written Participant’s information sheet to participate in the study.
11) Willing not to use any other marketed product on application site during the study period.
|
|
| ExclusionCriteria |
| Details |
1) Having any known allergy to test product ingredient.
2) Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
3) Participation in any similar consumer study within the past 90 days.
4) Currently using any topical medications.
5) Any exceptions to the inclusion/exclusion criteria will be considered on a case-by case basis and will be documented in the case report form.
6) Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc.).
7) Have participated in a study with the eyes as the target area within 6 weeks of the start of the study.
8) Be involved in any aspect of study administration, i.e., evaluating applying products, etc.
9) Have a history of sensitivity and/or adverse reactions to preparations intended for the eyes.
10) Currently having any eye infections or irritation.
11) The participant is having any sensitivity to eye make-up.
12) Currently have any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study.
13) Currently using any topical medications on the face or any medications intended for the eyes.
14) Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) on the days of the study.
15) Have any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results.
16) Currently taking any prescription pain medications.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of the test product for change in:
1. Skin Hydration
2. Skin overall dryness
3. Consumer Perception Questionnaire
4. Ocular irritation
5.degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, and lacrimation |
From the baseline before test product usage on Day 01 and after test product usage at T0 (+20) mins on Day 01. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
NA |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
28/02/2026 |
| 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 an open-label, prospective, single-centre, consumer in-sight and instrumental evaluation study designed to evaluate Hydrating Cleanser in Healthy Adult Male and Female Participants. The study population will include 24 adult male and female participants aged 18–55 years (both inclusive). All assessments will be conducted on a single study day at baseline, pre-usage of the test product and at T0 (+20) mins post usage of the test product. Assessments of the test product will be done as mentioned below: · Skin Hydration Level - Corneometer® CM 825 · Skin Digital Photography Visual Appearance® – VisioFace® RD · Overall Dry Skin - Dermatologically Scoring Scale · Consumer perception regarding the effectiveness of test product regarding the cleansing of dirt, oil, makeup, sunscreen and pollutants through 5-point Likert Scale The saline screening will only be performed at the first visit. There must be at least 5 minutes wait in between the saline and product application, for any saline layover effect. 10 µl of the 10% solution of the test product dissolved in the distilled water will be added to the one eye (conjunctival sac) and control product to another eye.
The subjects will then be asked to open their eyes and to rate the intensity of perceived discomfort/irritation using the Stinging/Discomfort Scale. This score will be recorded on the case report form. |