| CTRI Number |
CTRI/2025/09/094374 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of TediBar Ceramax Bathing Bar in Babies aged 0-36 months. |
|
Scientific Title of Study
|
An Open-Label, Single-Centre, Prospective, Interventional, Clinical Study to Evaluate the Safety, Efficacy and In-Use Tolerability Study of TediBar Ceramax Bathing Bar in Infants and Toddlers aged 0-36 months. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250020-TP_1.0_18Aug 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Shah MD Paediatrician |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota,Ahmedabad
Ahmadabad
GUJARAT
Dr Nayan Patel
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Mahesvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382421
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Torrent Pharmaceuticals Limited
Torrent House,
Off Ashram Road,
Ahmedabad 380009, Gujarat, India
|
|
|
Primary Sponsor
|
| Name |
Torrent Pharmaceuticals Limited |
| Address |
Torrent House,
Off Ashram Road,
Ahmedabad 380009, Gujarat, India
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Vipul Shah MD Paediatrician |
Om Children Hospital. |
304-305, 3rd Floor,
Silver Star Commercial complex
Above SBI, Silver star cross road.
Chandlodiya, Road, Gota,
Ahmedabad, Gujarat 382481
Phone: +91 7043186849
Ahmadabad
GUJARAT |
09909013286
consultant@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 |
0-36 months babies with dry and sensitive skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NA |
| Intervention |
Tedibar Ceramax bathing bar |
Mode of usage: Wet the baby’s face and body with water. Gently apply the bathing bar directly to the skin or onto hands to work up a rich lather. Massage the lather over the babys skin using gentle, circular motions. Rinse thoroughly with clean water and pat dry with a soft towel.
Frequency: Use once daily during the baby’s bath
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight
usage Period: 15 Days
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
1. Overall Good health of the baby is determined by medical examination and history evaluated by Investigator.
2. The subject may be of either sex, aged 0–36 months at the time of parental consent, and must have been of normal birth weight as determined by the physician. .
3. Overall healthy baby as per the Paediatrician.
4. Babies with dry and sensitive skin as determined by the paediatrician will be enrolled in the study.
5. Baby is in a healthy condition having exclusively breast-fed up to the age of 6 months.
6. Babies’ parent/legal guardian, preferably willing to give a voluntary written informed consent i.e. parental informed consent and agree to complete study activities and come for regular follow-up with a subject.
7. Medically stable babies without any requirement of drugs interventions, procedures, nutraceutical or other health supplement
8. The babies’ parent/legal guardian for their child is preferably willing to abide by and comply with the study protocol.
9. The babies should not participate in any other clinical study during participation in the current study.
|
|
| ExclusionCriteria |
| Details |
1. Babies with known history of allergies to any of the components (Ceramides and Hyaluronic acid) of Tedibar Bathing Bar.
2. Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterial or antifungals within one week prior to baseline visit.
3. Babies who would not be considered suitable for topical therapy.
4. History of sensitivity to the study product, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator
5. Babies who have a known history or present allergic condition that may require medical attention.
6. Babies’ who have Chronic illness which may influence the cutaneous assessment
7. Babies not willing to stop the use of other soaps during study period.
8. Babies has participated in a similar clinical investigation in the past four weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the efficacy of the test product by assessing change in skin hydration from baseline before usage and post usage of test product.
2. To evaluate the efficacy of the test product by assessing change in skin barrier function from baseline before usage and post usage of test product.
3. To evaluate the efficacy of the test product by assessing change in pH balance from baseline before usage and post usage of test product.
|
To evaluate the effectiveness of test product by assessing change in skin hydration evaluated through Corneometer® CM 825 from baseline on Day 01 and Day 15.
To evaluate the effectiveness of test product by assessing change in skin barrier function evaluated through TEWAMeter® TM Hex from baseline on Day 01 and Day 15
To evaluate the effectiveness of test product by assessing change in skin pH evaluated through pH meter from baseline on Day 01 and 15.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the efficacy of the test product by assessing change in skin dryness from baseline before usage and post usage of test product. |
1. To evaluate the effectiveness of test product by assessing change in skin dryness through Overall Dry Score (ODS) evaluated by paediatrician trained evaluator and paediatrician from baseline on Day 01 (prior to product usage) and post usage assessments on Day 15 (±2 Days). |
| 2. To evaluate the efficacy of the test product by assessing change in skin mildness, irritation and dryness from baseline before usage and post usage of test product. |
2. To evaluate the effectiveness of test product by assessing change in skin mildness, irritation and dryness evaluated through Investigator assessment scale from baseline on Day 01 (prior to product usage) and post usage assessments on Day 15 (±2 Days). |
| 3. To evaluate the efficacy of the test product by assessing change in Mother’s Feedback questionnaire from baseline before usage and post usage of test product. |
3. To evaluate the effectiveness of test product by assessing change in Mother’s Feedback questionnaire evaluated 5-point Likert scale in terms of no more tears, mild and soothing fragrance, mild and gentle on baby’s skin from baseline on Day 01 (prior to product usage) and post usage assessments on Day 15 (±2 Days). |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2025 |
| Date of Study Completion (India) |
26/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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,
prospective, single-arm clinical study designed to evaluate the safety,
efficacy, and in-use tolerability of the Tedibar Ceramax bathing bar in
infants and toddlers aged 0 to 36 months.
A total of 30 participants—including
infants and toddlers with dry and sensitive skin—will be enrolled. The age group
includes participants from birth (0 months) up to 36 months, with at least 1–2
infants aged 0 months. Infants aged 0 months will be excluded from instrumental
assessments such as Corneometer® CM 825 and TEWAMeter®
TM Hex evaluations.
Screening of potential participants will
be performed based on the study’s inclusion and exclusion criteria, only after
obtaining written informed consent from the parent(s) or legal guardian(s).
Prior to the enrolment visit, parent(s)/legal guardian(s) will be contacted telephonically
by the recruiting department.
The study includes two scheduled
visits over a period of 15 days (±2 days) from the
date of enrolment:
·
Visit 01 (Day 01): Screening, enrolment, and informed consent documentation
·
Visit 02 (Day 15 ± 2 Days): Post-product application assessments and end-of-study
procedures |