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A clinical study to evaluate the effect of a Diaper Rash Cream in Healthy Babies of 6 to 36 Months of Age.

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. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066744
Enrollment
36
Registered
2024-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

None listed

Interventions

Intervention1: 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 appli

Sponsors

Uprising Science Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Assessment of severity of rashes by a Pediatrician using overall severity scoring scaleTimepoint: Day 01 (before application), Day 02 (i.e., 24 hours (+ 2 hours) post application), Day 07 and Day 14—

Secondary

MeasureTime frame
Assessment of erythema of the affected area using Mexameter® MX 18Timepoint: Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14;Assessment of product’s mildness and gentleness on baby’s skin by a Pediatrician using 5-point grading scaleTimepoint: 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/VapometerTimepoint: Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14;Product Perception by taking feedbackTimepoint: Day 01 (before application), Day 02 (i.e., 24 hours (plus 2 hours) post application), Day 07 and Day 14—

Countries

India

Contacts

Public ContactDr Parth Joshi

Cliantha Research

ssethi@cliantha.com9825784942

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026