Health Condition 1: L088- Other specified local infections of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Godrej�s (GOOD NIGHT) after-bite roll on: Blue Chamomile 8.8 mg , Calendula extract 17.6 mg , Lavender oil 17.6 mg, Tea tree oil 8.8 mg, Coconut oil 17.6 mg and excipients Q.S R
Sponsors
Godrej Consumer Products Pvt Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: Participants of either sex aged more than 3 months of age. Participants/parents/guardians who are able to comply with all study requirements with a willingness to participate and give written informed consent(parent/guardian) voluntarily. Participants with at least 2 mosquito bites in any part of the arm, leg or face. Familiarity with an immediate mosquito bite reaction. History of immediately responding to mosquito bites with itching. Willing and able to refrain from consuming anti-histamines, corticosteroids, or Non- Steroid Anti-Inflammatory Drugs (NSAID,) for a time period of 1 week prior to the beginning of the study, and continuing throughout the course of the study. Willing to abstain from the use of insect repellant and/or any treatment other than the test device for the relief of mosquito bite symptoms until after the study
Exclusion criteria
Exclusion criteria: Known allergy to compounds of investigational product. No history of prior affliction with mosquito bites. History of lack of reaction to mosquito and/or other insect bites that includes itching. Current use of steroids. Use of insect repellants during the week prior to study start. Presence of any cardio vascular co morbid conditions. Epilepsy or other neurological disorders. Severe case of itching or erythema. Diabetes. Any skin or other disease or illness that can cause or influence skin itching, such as Psoriasis. Participation in research over the preceding 90 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the onset of relief in Itching and reduction in inflammation. Changes in 0-10 VAS itching ratings, and changes in total area of mosquito bite erythema, at 1 min, 2 min, 5 min, 10 min, 15 min and 30 min evaluation period. Photographic assessment will be done pre and post treatment. Clinical score for assessment of erythema and edema on a scale of 0-4 0 ââ?¬â?? no reaction 1 ââ?¬â?? very slight erythema and very slight edema 2 ââ?¬â?? slight erythema and slight edema 3 - moderate erythema with moderate edema 4 ââ?¬â?? severe erythema with severe edema All the data will be compared between the test and placebo. Timepoint: To assess the onset of relief in Itching and reduction in inflammation. Changes in 0-10 VAS itching ratings, and changes in total area of mosquito bite erythema, at 1 min, 2 min, 5 min, 10 min, 15 min and 30 min evaluation period. Photographic assessment will be done pre and post treatment. Clinical score for assessment of erythema and edema on a scale of 0-4 0 ââ?¬â?? no reaction 1 ââ?¬â?? very slight erythema and very slight edema 2 ââ?¬â?? slight erythema and slight edema 3 - moderate erythema with moderate edema 4 ââ?¬â?? severe erythema with severe edema All the data will be compared between the test and placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor for any adverse events, Hypoallergenic effect and its safety on skin during the study period All the data will be compared between the test and placebo. Timepoint: 1st and 2nd day | — |
Countries
India
Contacts
Public ContactDr Ramesh Kannan
SRM Medical College Hospital
Outcome results
None listed