CTRI/2026/03/105667Not yet recruitingNot Applicable
A Clinical Study to Evaluate the Safety and Tolerability of Tedibar Ceramax Head to Toe Bodywash in Paediatric Population.
Torrent Pharmaceuticals Ltd. Research Centre1 site in 1 country35 target enrollmentStarted: March 20, 2026Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 35
- Locations
- 1
Study Overview
Brief Summary
Participants will be screened according to the inclusion and exclusion criteria, and eligible participants will be enrolled after obtaining written parental consent.
The test product will be provided to parents/caregivers with instructions to use it during the child’s regular bathing routine at least once daily for 28 days.
Dermatological assessments, paediatrician’s evaluations, instrumental measurements of skin hydration, and parent/caregiver feedback will be conducted at Baseline, 30 minutes after the first application (Timm), Day 14 (Week 2), and Day 28 (Week 4).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 24.00 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and female trial participant in the age group, day 1 to 24 months of age on the day of enrolment.
- •Trial participant in general good health as determined by a paediatrician or dermatologist (as applicable) by a recent medical history.
- •Trial participant’s (parent or LAR) willing to give a voluntary written informed consent and agree to come for follow up.
- •Trial participant’s (parent or LAR) agreeing not to use any other product of the same nature and change any habit or other regular products during the study period.
- •Trial participant’s (parent or LAR) willing to abide by and comply with the study protocol requirement for his/her child.
Exclusion Criteria
- •A known history or present condition or any other concern that may require medical attention.
- •Trial participant deemed unfit to participate in the study based on the general health and hygiene
- •Trial participant having active skin diseases which will interfere with the test results.
- •Trial participant who has mild to moderate signs of local irritations like erythema, dryness, scaling/peeling, urticaria, acneiform eruptions, allergic reaction will be considered but severe signs will be avoided.
Investigators
Dr Sharil P Hedge
MS Clinical Research Pvt. Ltd
Study Sites (1)
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