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Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of TediBar Ceramax Head to toe Bodywash in Infants and Toddler up to 2 Years of age.

A Clinical Study to Evaluate the Safety and Tolerability of Tedibar Ceramax Head to Toe Bodywash in Paediatric Population. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105667
Enrollment
35
Registered
2026-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

None listed

Interventions

Intervention1: Tedibar Ceramax Head to Toe Bodywash: The product is a topical cosmetic body wash that will be applied during bathing using a small quantity on wet skin and scalp, gently lathered from

Sponsors

Torrent Pharmaceuticals Ltd. Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female trial participant in the age group, day 1 to 24 months of age on the day of enrolment. 2. Trial participant in general good health as determined by a paediatrician or dermatologist (as applicable) by a recent medical history. 3. Trial participant s (parent or LAR) willing to give a voluntary written informed consent and agree to come for follow up. 4. 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. 5. Trial participant s (parent or LAR) willing to abide by and comply with the study protocol requirement for his/her child.

Exclusion criteria

Exclusion criteria: 1. A known history or present condition or any other concern that may require medical attention. 2. Trial participant deemed unfit to participate in the study based on the general health and hygiene 3. Trial participant having active skin diseases which will interfere with the test results. 4. 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.

Design outcomes

Primary

MeasureTime frame
1. Safety and tolerability of the test product assessed by dermatological evaluation and paediatrician s assessment. 2. Improvement of skin hydration achieved based on Corneometer measurementsTimepoint: Baseline, 30 minutes after first application, Day 14, Day 28—

Secondary

MeasureTime frame
Safety, tolerability, efficacy perception, and product acceptability achieved based on parent/caregiver feedback questionnaire responsesTimepoint: Baseline, 30 minutes after first application, Day 14, Day 28—

Countries

India

Contacts

Public ContactSudhanthiran S

MS Clinical Research Pvt. Ltd

ritambhara@msclinical.com8040917253

Outcome results

None listed

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