| CTRI Number |
CTRI/2026/03/106358 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Clinical safety and efficacy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of Eltior Skin Barrier Moisturizer in varied skin types. |
|
Scientific Title of Study
|
An Open Label, Interventional, Prospective Clinical Study to Assess the Safety and Efficacy of Eltior Skin Barrier Moisturizer to Evaluate Hydration and Skin Barrier Function for varied skin types in Healthy Human Participants. |
| Trial Acronym |
MOIST |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB260009-RV_1.0_24Feb26 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel MBBS |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel MBBS |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
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 [Manufacture 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, India - 382481.
Ahmadabad
GUJARAT
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 |
oily, dry, normal, sensitive, or combination skin types. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eltior Skin-Barrier Moisturizer |
Mfg by: Zymo Cosmetics
Marketed By: Relaner Ventures Pvt. Ltd.
Mode of Usage: Apply the moisturizer evenly using gentle circular motions. Do not massage excessively. Allow full absorption of test product.
Frequency: Twice daily
Duration of application: 15 days
Route of administration: Topical
Dosage Form: Semi-solid
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 18 to 55 years at the time of consent.
2.Sex: Healthy males and non-pregnant, non-lactating female participants having oily, dry, normal, sensitive or combination skin type.
3.Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
4.Participants forearm must be free of cuts, tattoos, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tan, excessive hair or open wounds on or near the test sites.
5.If the participant is of 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.
6.Participants who commit not to use medicated skincare products other than the test product for the entire duration of the study.
7.Participants are not allowed to participate in any other study until this study is complete.
8.Patients are willing to give written informed consent and are willing to come for regular follow up.
9.Participants must agree to record each use of the test products in the participant’s diary card on daily basis.
10.Participant who have not participated in a similar study in the past three months. |
|
| ExclusionCriteria |
| Details |
1.Participants with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
2.Participants that are pregnant and/or breastfeeding.
3.The participant has a known allergy or sensitivity to any cosmetic product.
4.The participant 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 participant.
5.The participant is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
6.History of chronic illness which may influence the cutaneous state. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of the test product in terms of change in skin hydration using Corneometer® CM 825.
2. To evaluate the effectiveness of the test product in terms of change in skin barrier function using Tewameter® TM Hex.
3. To evaluate the effect of test product in terms of repair skin barrier damage following standardized tape stripping induced barrier disruption using Tewameter® TM Hex and Corneometer® CM 825.
|
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 min on Day 01, Day 02 and Day 15 (±2 Days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of the test product in terms change in skin texture i.e., skin smoothness, skin dryness, skin roughness and skin scaliness using Visioscan VC 20 Plus. |
Baseline before usage of the test product on Day 01 and after usage of the test product at T20 min on Day 01, Day 02 and Day 15 (±2 Days). |
| To evaluate the effectiveness of test product in terms of change in visual and tactile assessment of skin including skin scaliness, skin roughness, skin redness, skin itchiness, skin dryness and skin smoothness by dermatologist trained evaluator or dermatologist |
Baseline (Day 01) before usage of test product and after usage of test product at T20 min on Day 01, Day 02 and Day 15 (±2 Days). |
| To evaluate the effectiveness of test product in terms of change in total acne lesion using Visiopor® PP34N. |
Baseline (Day 01) before usage of test product and after usage of test product at T20 min on Day 01, Day 02 and Day 15 (±2 Days). |
| To evaluate the effectiveness of test product in terms of change in comedones by dermatologist trained evaluator or dermatologist. |
Baseline (Day 01) before usage of test product and after usage of test product at T20 min on Day 01, Day 02 and Day 15 (±2 Days). |
| To evaluate the effectiveness of test product in terms of Visual Analogue Scale for itching and redness. |
Baseline (Day 01) before usage of test product and after usage of test product at T20 min on Day 01, Day 02 and Day 15 (±2 Days). |
| To evaluate the effectiveness of test product in terms of change in appearance through digital photographs by Nikon Digital Camera D3300. |
before tape stripping and after tape stripping on Day 01 and after test product usage at T20min, Day 02 and Day 15 (±2 Days). |
| To evaluate the effectiveness of test product by assessing change in subjective product perception questionnaire through 5-point Likert scale. |
From baseline on Day 01 and product usage at T 20min, Day 02 and Day 15 (±2 Days). |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/03/2026 |
| 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="15" |
|
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, single-centre, single-arm, prospective interventional clinical
study designed to evaluate the safety and efficacy of Eltior Skin Barrier Moisturizer
in improving skin hydration and enhancing skin barrier function in healthy
participants across all skin types.
Up to 30 participants
including both males and non-pregnant, non-lactating females, aged 18 to 55
years (inclusive) will
be enrolled in the study to complete 25 participants for the study. Participants will be enrolled in an equal ratio across oily, dry,
normal, sensitive, and combination skin types
The potential
participants will be screened as per the inclusion & exclusion criteria
only after obtaining written informed consent from the participants. Participants
will be contacted telephonically by recruiting department prior the enrolment
visit.
The participants
will be instructed to visit the facility as per the below visits.
ü Visit 01
(Day 01): Screening, Enrolment, Baseline Evaluations,
Product Usage, Post Usage Evaluations
ü Visit 02
(Day 02): Evaluations
ü Visit 03
(Day 15 ±2 Days): Final
Evaluations, End of Study |