| CTRI Number |
CTRI/2026/01/102475 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Validation Study ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Skin Assessment for lipid restore. |
|
Scientific Title of Study
|
Validation of Skin Instrumentation to Detect Ceramide-Driven Lipid Replenishment - Assessing Skin Glow, Hydration, Trans Epidermal Water Loss, Skin surface assessment, Sebum and Least-Reflection Factor. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250045-NB-V _1.0 09 Jan 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 Pvt Ltd 313 Silver Radiance 4 Gota
Ahmadabad
GUJARAT
382481
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 Pvt Ltd 313 Silver Radiance 4 Gota
GUJARAT
382481
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 Pvt Ltd 313 Silver Radiance 4 Gota
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| 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 |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India - 382481
|
| Type of Sponsor |
Other [Contract Research Organization ] |
|
|
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 |
313, NovoBliss Research Pvt Ltd |
NovoBliss Research Pvt. Ltd. 313, Silver Radiance-4, Gota
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 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Product |
Topical Application Frequency: Single Application Spread the cream in the same direction. |
| Intervention |
Marketed Test Product |
Topical Application Frequency: Single Application Spread the cream in the same direction.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 to 55 years old (both inclusive) at the time of consent.
2) Sex: Healthy male and non-pregnant/non-lactating females.
3) Subject having normal, dry and sensitive skin.
4) Females of childbearing potential must have a self-reported negative pregnancy test.
5) Subject are generally in good health.
6) Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
7) If the subject 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.
8) Subjects are willing to give written informed consent and are willing to come for regular follow up.
9) Subjects who commit not to use any other skincare products for the entire duration of the study.
10) Subject who has not participated in a similar investigation in the past three months.
11) 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) Subject having allergic response to the ink.
4) Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
5) Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
6) History of alcohol or drug addiction.
7) Subjects using other marketed products during the study period.
8) Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
9) Pregnant or breastfeeding or planning to become pregnant during the study period.
10) History of chronic illness which may influence the cutaneous state.
11) Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the effects of ceramide-containing moisturizer versus water application on skin parameters:
•Skin Glow and least reflection factor – Skin Glossymeter GL 200
•Skin Hydration – Corneometer® CM 825
•TEWL – Tewameter TM Hex
•Skin Smoothness, Roughness, Skin Scaliness – VisioScan® VC 20 Plus.
•Sebum Level – Sebumeter SM 825
|
At baseline (before application) and at post-application at T15 mins.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To examine correlations between the least-reflection factor—particularly hydration & skin surface shine to evaluate its potential utility as an integrated indicator of skin reflection factor |
At baseline & post-application at T15 mins. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
10/02/2026 |
| 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 a single-center, open-label, split-face, site-randomized validation study, NB250045-NB-V designed to establish and confirm the reliability, reproducibility, and sensitivity of various skin measurement methods. Evaluator blinding will be implemented to minimize observer bias. Each subject will serve as their own control, with right side of the face receiving the ceramide-containing moisturizer and the left side receiving water application as the control. This split-face approach reduces inter-subject variability and enables direct intra-individual comparison of the measurement methods across treated and control sites. The study involves a single on-site visit for each subject. Baseline (pre-application): Subjects will undergo acclimatization in a controlled environment, after which baseline assessments will be performed for skin parameters on both test and control sites. Application phase: The ceramide-containing moisturizer and water control will be applied to the randomized sites under investigator supervision. Post-application assessments: Instrumental evaluations will be done at T15 mins following product application. |