FindTrial
Sign In

A clinical trial to evaluate the dermatological safety and potential allergenicity of Odomos Oil and its vehicle on skin of healthy children.

Double blinded Randomized Controlled Study to evaluate the dermatological safety of Odomos Oil and its vehicle by repeated open application sensitivity test on upper and lower limbs of healthy children. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/002962
Enrollment
72
Registered
2010-12-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Odomos oil: Mosquito Repellent Control Intervention1: Light Liquid Paraffin:

Sponsors

DABUR INDIA LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ? Healthy children ? Subjects age group 2 - 12 year. ? Parent/Legally acceptable representatives ready to sign the informed consent. ? Subject willing to give the consent (if applicable) ? Subjects ready to follow instructions during the study period. ? Subjects willing to come for regular follow up.

Exclusion criteria

Exclusion criteria: ? Infection, allergy on the exposed area, that is, upper and lower limbs. ? Skin allergy antecedents or atopic subjects ? Hyper sensitivity to any component of the tested products ? Cutaneous disease which may influence the study result ? Chronic illness which may influence the cutaneous state. ? Subjects on oral corticosteroid with dose >10mg/day ? Subject in an exclusion period or participating in any other cosmetic or therapeutic trial. ? Any underlying medical illness including diabetes, liver disease or history of HIV, or any other serious medical illness

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to evaluate the dermatological safety and potential allergenicity of Odomos Oil and its vehicle on skin of healthy children aged 2 to 12 years divided into 3 subsets of age groups (2-5 completed years, 6-8 completed years and 9-12 completed years).Timepoint: Approximately 30 days for each subject—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Mukta Sachdev

Dabur India Limited

arun.gupta@dabur.com01204378400

Outcome results

None listed

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