| CTRI Number |
CTRI/2023/02/049841 [Registered on: 17/02/2023] Trial Registered Prospectively |
| Last Modified On: |
29/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Tolerability and In-use efficacy] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To check Safety, Tolerability and effectiveness of HBWW-052005 |
|
Scientific Title of Study
|
An open label clinical study to evaluate the Safety, Tolerability and In-use
efficacy of HBWW-052005 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/CPD/003/2023 Version 01, Dated 19 Jan 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat, India Gandhinagar GUJARAT 382421 India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat, India Gandhinagar GUJARAT 382421 India
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar, Gujarat, India Gandhinagar GUJARAT 382421 India
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company Makali, Bengaluru 562 162, India |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Makali, Bengaluru 562 162, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nirav Patel |
Ashirwad Children Hospital, Vaccination Centre & Dental Care |
Ashirwad Children Hospital, Vaccination Center & Dental Care
219, 2nd Floor, Centre Point,
Opp. Vrundavan Heights,
Nr. Savvy Swaraj, New S.G.Road,
Vandematram to Godrej Garden City Road,
Vandematram-Gota, Ahmedabad, Gujarat - 382481
Ahmadabad
GUJARAT |
91-79-48983895
consultant@novobliss.in |
| Dr Nayan Patel |
NovoBliss Research Pvt. Limited |
Department - Clinical Trials Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat – India
Ahmadabad
GUJARAT |
9909013286
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 subjects in the age group as below (inclusive of both genders) ≥18-≤45 years, ≥ 2 - -≤12 years, 0 months – -≤2 years, Premature babies (babies born before 37 weeks) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HBWW-052005 - Baby Water Wipes |
How to Use: Pull out 1 wipe & gently clean the baby.
Frequency: Use as and when required
Time period: 3 days - Group 1, 2 and
28 days - Group 3, 4. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy subjects in the age group as below (inclusive of both genders)
a.Group 1: ≥18-≤45 years (both inclusive)
b.Group 2: ≥ 2 - -≤12 years (both inclusive)
c.Group 3: 0 months – -≤2 years (both inclusive)
d.Group 4: Premature babies (babies born before 37 weeks)
2.Healthy day 1 babies not requiring medical attention.
3.Babies with signs of atopic dermatitis (dry skin, itchy skin, redness, sensitive skin, rashes) who does not require medical/systemic treatment to be included. Included in group 2 (6 subjects) and group 3 (15 subjects) with signs of atopic dermatitis.
4.Subjects in general good health as determined from a recent medical history.
5.Subjects mother/legal representative, preferably mother willing to give a voluntary written informed consent and agree to come for regular follow up.
6.Subjects mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
7.Subjects should not participate in any other clinical study during participation in the current study.
|
|
| ExclusionCriteria |
| Details |
1.A known history or present condition of allergic response to any other concern that may require medical attention.
2.Chronic illness which may influence the cutaneous state.
3.Subjects not willing to stop the use of other baby powders during the study period.
4.Subjects participated in any other clinical study past 4 weeks
5.To determine the experience of test product on baby skin through subjective questionnaires on cleaning as pure as water, gentle cleansing without making skin dry for new-born skin, Suitable/ safe for newborn skin, suitable for sensitive skin babies, safe for use from day 1 of the baby, suitable/ safe for premature baby. keeps skin refreshed, keeps baby skin soft and smooth, mildness and gentleness tested in babies and safe on new-born
6.Local tolerance evaluation by the investigator.
7.Monitoring of AEs and SAEs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the skin mildness, gentleness and irritability on skin by the investigator. |
1. 2 - 12 years Day 01 and Day 03
2. 18 - 45 years: Day 01 and Day 03
3. 0 - 2 Years: Day1, Day 7, Day 28
4. Premature babies: Day1, Day 7, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the experience of test product on baby skin through subjective questionnaires |
2 - 12 years, 18 - 45 years: Day 03
0 - 2 Years, Premature babies: Day 7, Day 28 |
| To evaluate the product safety of skin by local intolerance evaluation by investigator |
2 - 12 years, 18 - 45 years: Day 03
0 - 2 Years, Premature babies: Day 7, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2023 |
| Date of Study Completion (India) |
13/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study Objective: An open label clinical study to evaluate the Safety, Tolerability and In-use efficacy of HBWW-052005. Study Design : An open label, sequential, 4 groups clinical safety and efficacy study. Study enrollment will be sequential following the groups. Both male and female subject - Group 1: 18-45 years Group 2: 2 -12 years Group 3: 0 months – 2 years Group 4: Premature babies Study Methodology: All eligible subjects will be enrolled into the study after informed consent procedure. Subject/ Parents of the baby will be provided with the informed consent document and explained about the study in detail. Post informed consent process the baseline assessments will be completed. The subjects will then be provided with a test product and the subject’s mother will be instructed to use cream baby bar by the Investigator /study coordinator. Every subject will undergo the visits as scheduled per group. Group 1 and group 2 will have day 1 as screening/ baseline visit investigator assessment scale and at day 3 visit investigator assessment scale, subjective questionnaire assessment and local intolerance will be evaluated. Group 3 and group 4, at day 1 as screening/ baseline visit investigator assessment scale will be done. At day 7 and day 28 investigator assessment scale, subjective questionnaire assessment and local intolerance will be evaluated. Day 7 will be telephonic visit for group 4 only subjective assessment and local intolerance will be asked during the telephonic visit. In the presence of the investigator the instructions will be given to use the test product at home. Study Duration: This study is planned for 03 days for group I and Group II, 28 days for Group III and Group IV. Number of subjects: 81 evaluable subjects Direction to Use: Pull out one wipe & gently clean the baby. Carefully reseal the pack flap to keep wipes fresh and moist for the future. |