| CTRI Number |
CTRI/2024/05/066744 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effect of a Diaper Rash Cream in Healthy Babies of 6 to 36 Months of Age. |
|
Scientific Title of Study
|
An Open Label, Single Arm Clinical Study to Evaluate Safety, In-Use Tolerability and Efficacy of a Diaper Rash Cream in Healthy Babies of 6 to 36 Months of Age. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04313; Version: 01, Dated 15 Apr 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devang Gokalani |
| Designation |
Principal Investigator |
| Affiliation |
Shreeji Hospital |
| Address |
101-103 First Floor,
Magnate Square, Sardar Chowk,
New Ranip, Ahmedabad – 382470, Gujarat.
Ahmadabad
GUJARAT
382470
India |
| Phone |
9033981866 |
| Fax |
|
| Email |
devanggoklani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Study Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off. Sindhubhavan Road,
Nr. Mann Party Plot Cross Road, Bodakdev,
Ahmedabad-380054-India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
| Uprising Science Private Limited, Plot No. F-2109, RIICO Industrial Area, Ramchandra Pura (Sitapura Extension), Vidhani, Jaipur, Rajasthan – 303905 (India). |
|
|
Primary Sponsor
|
| Name |
Uprising Science Private Limited |
| Address |
Plot No. F-2109, RIICO Industrial Area,
Ramchandra Pura (Sitapura Extension), Vidhani,
Jaipur, Rajasthan – 303905 (India).
|
| Type of Sponsor |
Other [Manufacturers of personal care products] |
|
|
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 Devang Goklani |
Shreeji Hospital |
101-103 First Floor,
Magnate Square, Sardar Chowk,
New Ranip, Ahmedabad – 382470, Gujarat.
Ahmadabad
GUJARAT |
9327705003
devanggoklani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy babies of both genders between the age group of 6 to 36 months having good health as determined from a recent medical history and the pediatrician. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Minimalist Pediatrics Zinc Oxide + B5 Healing Ointment |
1.5 to 2.5 gm of test product (as per requirement) to be applied directly on the baby’s affected rash site. The cream to be applied with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
1) Babies who are generally in good health as determined from a recent medical history and the pediatrician.
2) Babies having an "Overall Severity Score" greater than or equal to 1.5 as determined by the trained evaluator.
3) Babies who wear diapers for at least 12 hours per day.
4) Babies delivered after complete gestation (more than 38 weeks). |
|
| ExclusionCriteria |
| Details |
1) Babies mother/legal caretaker not willing to stop the use of other baby products other than the provided test product on the affected area during the study period.
2) Babies with chronic illness / systemic illness which may influence the cutaneous state.
3) Babies on any systemic medication / undergoing treatment for skin disorders.
4) Babies with diarrhea/ bowel incontinence.
5) Babies who are currently being toilet trained.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of severity of rashes by a Pediatrician using overall severity scoring scale |
Day 01 (before application), Day 02 (i.e., 24 hours (+ 2 hours) post application), Day 07 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of product’s mildness and gentleness on baby’s skin by a Pediatrician using 5-point grading scale |
Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application, Day 07, Day 14 |
| Assessment of skin barrier function using TEWAmeter® TM300/Vapometer |
Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14 |
| Assessment of erythema of the affected area using Mexameter® MX 18 |
Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14 |
| Product Perception by taking feedback |
Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/06/2024 |
| Date of Study Completion (India) |
02/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
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, non-randomized,
single-arm, clinical study to evaluate safety, in-use tolerability and efficacy
of Diaper Rash Cream in healthy
babies with diaper rash.
The potential subjects will be screened as per
the inclusion and exclusion criteria only after obtaining written parental informed
consent from Baby’s mother/legal caretaker.
All eligible subjects will undergo clinical
evaluation by a Dermatologist, instrument evaluation and feedback from baby’s
mother/legal caretaker. Safety will be assessed throughout the study by
monitoring adverse events and local intolerances. |