| CTRI Number |
CTRI/2020/09/027574 [Registered on: 03/09/2020] 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 in use study |
|
Scientific Title of Study
|
Safety In-Use Study to Assess the Cutaneous Tolerance of Baby Diaper Rash Cream in Healthy Babies of 0 to 36 Months of Age |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00299, Version: 01, Dated 19 Aug 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
Ahmadabad
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
Telephone number 91 79 27602050
|
|
|
Primary Sponsor
|
| Name |
Azafran Innovacion ltd |
| Address |
Dishman Corporate House,
Jayantilal Park BRTS Bus Stop,
Iscon-Bopal Road, Ambli,
Ahmedabad, Gujarat 380009
Phone: 1800 102 7797
|
| 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) with mild to moderate diaper rash. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baby Diaper Rash Cream |
External Use Spread the Diaper Rash Cream generously on the baby’s buttocks and thighs area
Use daily for 14 days each time diaper change happens
|
| 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 to 36 months inclusive of both genders at the time of consent
2 Babies mother or legal representative preferably mother willing to give a voluntary written parental informed consent and agree to come for regular follow up.
3 APGAR score greater than 7 at 1 and 5 minutes with no resuscitation required at birth for babies of 0 to 7 days.
4 Babies general in good health as determined from a recent medical history.
5 Parent or guardian willing to use only the test product in the diaper area during the trial.
6 Parent or guardian willing to ensure that their child continues to wear their usual brand of diapers and will continue to clean their child during diaper changes using their usual products and method with the exception of ointments lotions creams or powders during the trial
7 Parent or guardian is willing to refrain from changing any other products whose use may have an effect on their child skin condition during the trial ie laundry detergents fabric softeners and products used to bathe the child.
8 Wear diapers 24 hours per day.
9 Present to the test facility for enrollment at baseline with diaper rash receiving an Overall Severity Score greater than or equal to 1.5 as determined by the trained evaluator.
10 Babies with mild to moderate rashes on buttocks and or thigh area assessed by Dermatologist or Dermatologist Validated Scorer using scoring scale will be included in the study.
11 Babies mother or legal representative preferably mother willing to abide by and comply with the study protocol.
12 Babies should not participate in any other clinical study during participation in the current study. |
|
| ExclusionCriteria |
| Details |
1. Babies’ mother/ legal caretaker not willing to stop the use of other baby body milk /lotion / diaper rash cream or any other baby body moisturizing product during the study period.
2. Chronic illness which may influence the cutaneous state.
3. Babies on any systemic medication.
4. Babies currently being toilet trained.
5. Babies participating in a similar clinical study, currently or during the previous 30 days.
6. Any baby, 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, eczema, 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. To evaluate rash skin overall severity scoring scale and Scoring for erythema redness dryness itching & rashes
2. Safety on skin mildness, gentleness and non-irritability of babies’ skin by using Pediatrician Assessment Scoring
3. Skin hydration using Corneometer® CM 825 or MoistureMeterSC
4. To evaluated on skin barrier function by transepidermal water loss (TEWL) using TEWAmeter® TM 300 or VapoMeter |
Day 01 Baseline and Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective Assessment Questionnaire from babies’ mother or legal caretaker |
Day 15 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/09/2020 |
| Date of Study Completion (India) |
12/03/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
The objective of this study is To evaluate the safety of Test product i.e. Baby diaper rash cream in
babies with daily repeated use for 14 consecutive days. 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, also determines the experience of rich creamy feel and
keeps the baby’s skin moisturized and hydrated, upon application relieving
dryness, redness, oedema, urticarial and any other reactions. The proposed
benefits are evaluated by the pediatrics, subjective assessment questionnaire
and instrumental evaluation by the
dermatologist/dermatologist trained evaluator and assessment questionnaire at
Day 01 and Day 15. |