Health Condition 1: L258- Unspecified contact dermatitis dueto other agents
Conditions
Interventions
None listed
Sponsors
Mother Sparsh Baby Care Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects between the age 0 months to 20 years of either sex. 2. Presence of atleast one qualifying insect-bite lesion or minor superficial non-infected abrasion suitable for topical treatment, with onset not more than 24 hours prior to screening. 3. Minimal inflammation as per TIS at the target lesion. 4. Subjects, Parents/guardians of subjects who agree to participate/allow their child to participate in this trial and provide signed consent for the same.
Exclusion criteria
Exclusion criteria: 1. Subjects greater than 20 yrs. 2. Subjects with open wounds, tattoos, local infection at the target lesion at screening or lesion characteristics precluding topical management. 3. Subjects using prohibited topical or systemic medication for the target lesion within the specified washout within 7 days, systemic antibiotics or oral corticosteroids within 14 days prior to enrolment. 4. Subjects with history of atopic dermatitis with active widespread eczematous involvement or Chronic skin disease at/around the target lesion. 5. Subjects judged by the investigator to be inappropriate for this trial (morbidities, infections etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the insect bite lesion size, insect bite severity, redness, nature, tenderness, swelling, exudates and itch severity as per investigators assessment following use of Insect Bite Relief Balm.Timepoint: From baseline to EOS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the in the anti-septic, inflammation andhealing property using TIS scores recorded by Investigatorand Subjects/ Parents / Guardian following use of Insect BiteRelief Balm.Timepoint: From baseline to EOS.;Mean change in the discomfort severity assessment (as per Investigator and Parent-reported Outcomes with FLACC Assessment Scale for Kids/ Toddlers/ Babies/ Infants; and Investigator and subject for Adults/ Adolescents).Timepoint: From baseline to EOS.;Mean onset of relief from pruritus following use of Insect Bite Relief Balm.Timepoint: From baseline to EOS.;Mean onset of relief from bite related other discomforts following use of Insect Bite Relief Balm.Timepoint: From baseline to EOS.;Complete recovery time from the onset of insect bite following use of Insect Bite Relief Balm.Timepoint: From baseline to EOS. | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed