None listed
Conditions
Interventions
Intervention1: Mosquito Repellent Fabric Patches
Duration- 16 Days: Manufactured by: Dabur India Limited
Route of administration: Topical (On fabric)
Mode of usage: Peel of the patch and stick it on c
Sponsors
Dabur India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Aged between 0 months and 36 months 2) Healthy male or female. 3) In good general health as determined by the Investigator on the basis of medical history. 4) Parent(s)/legally acceptable representative(s) willing to comply with study procedures and provide written informed consent as per regulatory requirements. 5) Not to use any other marketed product on application site during the study period.
Exclusion criteria
Exclusion criteria: 1) Has any known allergy to test product ingredient. 2) Has had any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc. 3) Has participated in any similar consumer study within the past 90 days. 4) Is currently using any topical medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the local skin intolerance (skin dryness, irritation, redness, swelling, itching, burning sensation, tingling, scaling, oedema, rashes) through Paediatrician Evaluation based on occurrence and severityTimepoint: Baseline and Day 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the occurrence & severity of any generalized allergic reactions, such as body itching, wheezing, coughing, sneezing, runny nose, watery eyes, eye irritation & conjunctivitis assessed by PaediatricianTimepoint: Baseline & Day 16;To assess the change in physiological parameters such as respiratory rate, body temperature & pulse rate by Paediatrician or paediatrician trained evaluatorTimepoint: Baseline & Day 16;To assess the Participant s mother s/ Caregiver feedback on products perception regarding the effectiveness of test products, including effectiveness in reducing the frequency of mosquito bites, spreadability, smell, smoothness of application, absorption, and non-stickiness, using a 5-point Likert scaleTimepoint: Day 16;To assess any adverse events either reported by parents/legal caretaker of subjects or as assessed by the Paediatrician / paediatrician trained evaluator such as nausea, vomiting, breathing difficulty and stomach crampingTimepoint: Day 16 | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Pvt. Ltd.
Outcome results
None listed