CTRI Number	CTRI/2023/07/055838 [Registered on: 28/07/2023] Trial Registered Prospectively
Last Modified On:	18/10/2023
Post Graduate Thesis	No
Type of Trial	PMS
Type of Study Modification(s)	Other (Specify) [Skin Care]
Study Design	Randomized, Parallel Group Trial
Public Title of Study	To assess the safety, tolerability, and suitability of Mother Sparsh Baby Wipes on Infant Skin compared to a cotton ball moistened with water.
Scientific Title of Study Modification(s)	Clinical Safety, Tolerability, and Suitability and to access clinical prevention of Irritant Diaper Dermatitis (IDD) with Mother Sparsh 99% Pure Water Unscented Baby Wipes on Infant Skin Compared to Cotton Ball Moistened with Clear Water as a Gold Standard for the Prevention of IDD: An Open-label, Comparative , Two-arm, real World Clinical Trial(Phase-IV Study)
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Veena BT  Address  No 1031 20th main road 5th block Rajajinagar Bengaluru Bangalore KARNATAKA 560010 India  Phone  9880033626   Fax     Email  veenaprabhubt@gmail.com
Details Contact Person Scientific Query	Name  Mr Hasan Ali Ahmed  Address  No 252 13th cross Wilson Garden Bangalore Bangalore KARNATAKA 560027 India  Phone  9886012598   Fax     Email  hasan@xplorahealth.com
Details Contact Person Public Query	Name  Mr Hasan Ali Ahmed  Address  No 252 13th cross Wilson Garden Bangalore KARNATAKA 560027 India  Phone  9886012598   Fax     Email  hasan@xplorahealth.com
Source of Monetary or Material Support	Mother Sparsh Baby Care Pvt Ltd Plot No 330 Industrial Area Phase 1 Panchkula 134113 Haryana INDIA
Primary Sponsor	Name  Mother Sparsh Baby Care Pvt Ltd  Address  Plot No 330 Industrial Area Phase 1 Panchkula 134113 Haryana INDIA  Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  Nil  Nil
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Veena BT  Sidvin Hospital Pvt Ltd  No 1031 20th main road 5th block Rajajinagar Bengaluru 560010 Bangalore   9880033626 veenaprabhubt@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Pranav Diabetes centre Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Healthy Human Volunteers  To prevent Irritant Diaper Dermatitis
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  Cotton Ball  Cotton Balls moistened with clear water as gold standard
Inclusion Criteria	Age From  1.00 Month(s) Age To  12.00 Month(s) Gender  Both  Details  1. Healthy male and female infants aged between 1 to 12 months. 2. Routine users of baby wipes. 3. Subjects mother or legal guardian preferably mother willing to give written informed consent and adhere to all the study procedures. 4. Subjects must not participate in any other study during participation in the current study.
ExclusionCriteria	Details  1. Subjects with had limb defects, admitted to the neonatal unit and receiving phototherapy 2. Subjects with non-traumatic impairment of epidermal integrity or evidence of skin disorder 3. Subjects with a chromosomal abnormality or other syndromic diagnosis 4. Subjects with known intolerance to baby wipes or baby wipes ingredients. 5. Subjects with psoriasis ichthyosis or a febrile illness. 6. Subjects taking any medication likely to influence the skin condition 7.Subjects mother or legal guardian preferably mother not willing to give informed consent
Method of Generating Random Sequence	Other
Method of Concealment	An Open list of random numbers
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  1.Frequency & severity of local tolerability symptoms using general clinical & dermatologic examination of skin assessment parameters  Day 1, Day 15
Secondary Outcome	Outcome  TimePoints  Change in skin pH in the diaper area from baseline to end of the study Mothers feedbacks on a subjective questionnaire on the study products Number of subjects with the study products emergent adverse event (AEs) & serious adverse events (SAEs)   14 days
Target Sample Size	Total Sample Size="60" Sample Size from India="60"
Phase of Trial Modification(s)	Phase 4
Date of First Enrollment (India) Modification(s)	10/08/2023
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	N/A
Brief Summary Modification(s)	The study has been designed to assess the safety, tolerability, and suitability of Mother Sparsh 99% Pure Water Unscented Baby Wipes on infant skin compared to a cotton ball moistened with water. The skin of babies is very sensitive, and its barrier functions remain under development until around 12 months of age. About 50% of babies develop dermatitis after using diapers because it causes prolonged skin contacts with urine and faeces, occlusion of the skin, skin wetness, and friction. These issues increase proteolytic and lipolytic enzyme activities, the formation of ammonia, and skin surface pH, impeding normal skin microflora and affecting normal skin barrier integrity. Therefore, it is widely accepted that proper cleaning of the diaper area of babies is important. Water and cotton are commonly considered gold standard practices for IDD prevention, along with a healthy hygiene regimen. Over the past decade, the use of baby wipes as primary cleaning tools has increased. Millions of babies are likely to be exposed several times daily to disposable wipes until they complete toilet training. The key functions of a wipe are cleansing and removing faecal matter from the skin, both of which are largely accomplished through the use of cosmetic chemicals in baby wipes. These baby wipes are applied to the faces, hands, and skin of the diaper area, which may lead to skin irritation or dermatitis. In contrast, baby wipe-induced dermatitis has been reported in adults, raising concern among healthcare professionals about the use of baby wipes and encouraging them to use only water. In this regard, the US Association of Midwifery, Neonatal, and Women’s Health Nurses recommends detergent-free and alcohol-free wet wipes. Despite the absence of high-quality, controlled clinical studies addressing the safety and efficacy of baby wipes, their use has increased for cleansing the skin of newborns . Recently, a few studies have reported clinical data on the dermatologic effects of baby wipes. All studies indicated that wipes had good skin tolerability and no evidence of harm, even when used on dermatitis-prone skin. Therefore, a detailed safety assessment is necessary to ensure that baby wipes supplied to the market have proven safety and skin tolerability.