CTRI/2023/10/058788 [Registered on: 18/10/2023] Trial Registered Prospectively
Last Modified On:
24/11/2023
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
To evaluate the safety and efficacy of Crème cleansing baby bar in 0-36 months babies.
Scientific Title of Study
Post Marketing Observational Study PMOS to Evaluate the Safety and Efficacy of Creme Cleansing Baby Bar HBCS-011701 On Babies with Atopic Dermatitis Sensitive Skin In 0-36 Months Babies.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
HWC/MSCD/CPD/009/2023 Version No: 1.0, Dated 19 July 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Mohit Poddar
Designation
Consultant
Affiliation
Poddar Hospital
Address
3510AB, Langar Ke Balaji Ka Rasta, Gangori Bazar, Near Neemdi Police Station, Jaipur 302001
Jaipur RAJASTHAN 302004 India
Phone
09829666655
Fax
Email
drmohitpoddar@gmail.com
Details of Contact Person Scientific Query
Name
Dr Soorya Narayan
Designation
Manager- Clinical Operations - MSCD & RD
Affiliation
Himalaya Wellness Company
Address
Room No 301,3rd Floor, Clinical Pharmacology, Research and Development Makali, Tumkur Road, Bangalore Rural, KARNATAKA – 562162, India
Bangalore Rural KARNATAKA 562162 India
Phone
918067549919
Fax
Email
dr.sooryanarayan.h@himalayawellness.com
Details of Contact Person Public Query
Name
Dr Swathi B
Designation
Clinical Team Lead - Personal Care - MSCD & RD
Affiliation
Himalaya Wellness Company
Address
Room No 301,3rd Floor, Clinical Pharmacology, Research and Development Makali, Tumkur Road, Bangalore Rural, KARNATAKA – 562162, India
Bangalore Rural KARNATAKA 562162 India
Phone
918067547232
Fax
Email
dr.swathi.b@himalayawellness.com
Source of Monetary or Material Support
Himalaya Wellness Company
NH 4, Makali, Tumkur Road, Makali Aluru Main Road
Opposite to JCB
Bangalore Rural, Karnataka, 562162
India
Primary Sponsor
Name
Himalaya Wellness Company
Address
NH 4, Makali, Tumkur Road, Makali Aluru Main Road
Opposite to JCB
Bangalore Rural, Karnataka, 562162
India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
JSS Medical Research Asia Pacific Private Limited
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India
Crème Cleansing baby bar supports natural lipid balance and prevents dehydration of the babys skin. It has many benefits for the baby’s skin, like provide mildness and gentleness on baby’s skin and preventing dryness as well as roughness, helps improving baby’s skin health. It is specially formulated with a skin friendly pH of 5.5 for babies with sensitive skin. The cleansing bar with rich creamy texture is enriched with the herbal ingredients such as Coconut, Aloe Vera and Mahua Butter are the natural moisturizers helps keep skin nourished and protected longer post bath. It is free from parabens and artificial colours. This rich creamy lather mildly cleanses while the goodness of natural moisturizers helps to keep skin nourished and protected longer post bath.
Dose- NA, Frequency- whenever required, Route- Topical, Duration- 14 Days
Comparator Agent
NA
NA
Inclusion Criteria
Age From
0.00 Day(s)
Age To
36.00 Month(s)
Gender
Both
Details
1.Subjects in the age group of 0 to 36 months (inclusive of both genders).
2.Subjects with Atopic Dermatitis with at least one of the following symptoms: dryness, itchiness, redness, flaky skin.
3.Subjects in general good health as determined by investigator.
4.Subjects mother/legal representative willing to give a voluntary written parent consent and agree to complete study activities and come for regular follow up with subject.
ExclusionCriteria
Details
1.A known history or present allergic condition that may require medical attention.
2.Chronic illness which may influence the cutaneous assessment.
3.Subjects not willing to stop the use of other baby bath products or soap during the study product.
4.Subjects who have 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
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the safety and efficacy of Test Product in study population.
14 days
Secondary Outcome
Outcome
TimePoints
NA
NA
Target Sample Size
Total Sample Size="500" Sample Size from India="500" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
STUDY
OBJECTIVE: To evaluate the safety and efficacy of Crème cleansing
baby bar on babies with atopic dermatitis – sensitive skin in 0-36 months
babies
STUDY DESIGN: An open label, post
marketing observational study.
Study
Methodology:
1. Parents/Legally
Acceptable Representatives (LARs) of the baby will be provided with the parental
consent document and explained about the study in detail.
2. Babies who fulfil the
selection criteria will be enrolled into the study after written parental consent.
3. The subject’s parent
/LAR will be provided with The Himalaya Crème cleansing baby bar, and they will
be instructed on the use the product by the study doctor/ coordinator.
4. Assessments will be
performed on Day 1/baseline and at the end of the study visit (Day 14) as
per the schedule of
events.
5. If subjects score for
Local intolerance is scored 1= Mild, 2=Moderate, 3=Severe, then the undesirable
effect page to be completed.
6. All undesirable
effects to be followed up till the event is stabilized or 7days whichever is
earlier
Study
duration: This
study is planned for 2 Weeks/14 days. The subjects must use the test product
for all 14 days.
Number
of Subjects: 500 subjects will be enrolled.
Study
Site: Thestudy will be conducted at 20 sites.
Directions to Use: Wet baby’s body with
lukewarm water, create lather in your hand, and gently apply on your baby’s
body. Cleanse and rinse off with water.