To assess the safety, tolerability, and suitability of Mother Sparsh Baby Wipes on Infant Skin compared to a cotton ball moistened with water.

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) - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/07/055838

Enrollment

Registered

2023-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Control Intervention1: Cotton Ball: Cotton Balls moistened with clear water as gold standard

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
1.Frequency & severity of local tolerability symptoms using general clinical & dermatologic examination of skin assessment parametersTimepoint: Day 1, Day 15	—

Secondary

Measure	Time frame
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)Timepoint: 14 days	—

Countries

India

Contacts

Public ContactMr Hasan Ali Ahmed

Xplora Clinical Research Services Pvt Ltd

hasan@xplorahealth.com9886012598

Outcome results