| CTRI Number |
CTRI/2020/08/026966 [Registered on: 04/08/2020] Trial Registered Prospectively |
| Last Modified On: |
29/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety in Use Study] |
| Study Design |
Other |
|
Public Title of Study
|
Safety study of baby cream |
|
Scientific Title of Study
|
Safety In-Use Study to Assess the Cutaneous Tolerance of Test Product i.e. Baby Cream in Healthy Babies of 0 to 36 Months of Age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00202 Version: 01, Dated 13 Jun 20 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
GUJARAT
380054
India |
| Phone |
9909013286 |
| Fax |
07966219549 |
| Email |
nkpatel@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Maheshvari Patel |
| Designation |
Associate Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department
Garden View Corporate House No 7
Opp Auda Garden
Bodakdev Ahmedabad 380054 India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9909013236 |
| Fax |
07966219549 |
| Email |
mnpatel@cliantha.com |
|
|
Source of Monetary or Material Support
|
| OM Childrens Hospital
304-305 Silver Star Commercial Complex
Silver Star Crossroads New Chandlodia
Ahmedabad 382481 |
|
|
Primary Sponsor
|
| Name |
Azafran Innovacion Limited |
| Address |
Dishman Corporate House,
Jayantilal Park BRTS Bus Stop,
Iscon-Bopal Road, Ambli,
Ahmedabad, Gujarat 380009 |
| Type of Sponsor |
Other [Cosmetics Industries] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
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 |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No. 7
Opp. Auda Garden
Bodakdev
Ahmedabad 380054
India
Ahmadabad
GUJARAT |
9909013286
07966219549
nkpatel@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Babies in the age group of 0 (including new born full term babies Day 1) to 36 months (both inclusive at the time of consent). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baby Cream |
External Use – Apply the Baby Cream in the morning after bath on baby’s face and body.
Use once daily for 14 days.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
1) Babies in the age group of 0 (including new born full term babies Day 1) to 36 months (inclusive of both genders) at the time of consent.
2) Babies general in good health as determined from a recent medical history
3) Babies mother/legal representative, preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
4) Babies mother/legal representative, preferably mother willing to abide by and comply with the study protocol.
5) Babies should not participate in any other clinical study during participation in the current study.
Additional Criteria for babies with atopic dermatitis:
6) Babies with mild to moderate atopic dermatitis assessed using TIS score and parental questionnaire as per dermatologist examination will be included in the study.
|
|
| ExclusionCriteria |
| Details |
1) Subject’s mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / cream or any other baby face/body moisturizing product during the study period.
2) Chronic illness which may influence the cutaneous state.
3) Subject on any systemic medication.
4) Subject with birth defects and anomalies.
5) Subject participating in a similar clinical study, currently or during the previous 30 days.
6) Any subject, in the Investigators opinion not considered suitable for enrollment.
7) A known history or present condition of allergic response to any other concern that may require medical attention.
8) Babies with medical history (past | present) of significant dermatological diseases or conditions, such as atopy, psoriasis, vitiligo or other conditions known to alter skin appearance or physiologic response (e.g. porphyria) chronic urticaria, or sunburn, rashes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The safety of the test product will be evaluated on the skin in terms of mildness, gentleness and non-irritability of babies’ skin by pediatrician assessment
2. The effect of test product will be evaluated on improvement in the skin hydration using Corneometer® CM 825 or Moisture Meter SC.
3. To evaluate dermatological tolerability in babies with atopic dermatitis by using Three-Item Severity (TIS) Score and Parental Questionnaire
|
1. Day 01 Before application, Day 15 after application
2. Day 01 Before application, Day 15 after application
3. Day 01 Before application, Day 15 after application
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Subjective assessment questionnaire will be evaluated from babies’ mother/ legal caretaker. [Refer Appendix V for subjective assessment questionnaire] |
1. Day 15 after application |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/08/2020 |
| Date of Study Completion (India) |
06/01/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is proposed to
evaluate and establish the benefits of the test product on mildness, gentleness
and non-irritability on baby’s skin and soothes the baby’s skin, keeps the
baby’s skin moisturized post bath upon application relieving dryness and to
show the improvement in the symptoms of atopic dermatitis. During the course of
the study, subject’s mother/ legal caretaker will record comments and opinions
about the product in a daily diary. The proposed benefits are evaluated by the dermatologist/dermatologist
trained evaluator and assessment questionnaire at Day 1 and Day 15. |