Health Condition 1: L20-L30- Dermatitis and eczema
Conditions
Interventions
Intervention1: CANISON PLUS CREAM: Two times a day for 28 days
Control Intervention1: TRIDERM CREAM: Two times a day for 28 days
Sponsors
Agio Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Children between the age group of 12 to 17 years both sexes age are inclusive 2 Children whose parents /guardians of the children who are willing to give written informed consent or AV recording as per the regulatory requirement 3 Informed consent with AV recording by study participants
Exclusion criteria
Exclusion criteria: 1 Participants with a history of hypersensitivity to any of the components of the medication being studied 2 Patients having history of renal liver failure and found out high level of adrenocorticoids level 3 Participants who need any other type of topical or systemic medication during the trial that might affect the course of the disease 4 Participants who have been treated with other topical medications during the 14 day period prior to the start of the trial 5 Participants who have received systemic corticosteroids or any other immunosuppressant medication during the 28-day period prior to the start of the study 6 Pregnant and nursing women 7 Any finding of clinical observation that is interpreted by the investigator as a risk to the patients participation in the study 8 Severely immune compromised patients 9 Use of any investigational drug currently or within 30 days prior to study entry 10 History of alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Percent improvement of individually measured signs of the disease in a given target area will be assessed objectively and quantified on a scale of 0 to 5 Timepoint: Baseline to end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Number of Days Required to Achieve Total Remission 2 Self Assessment of General Health 3 Assessment of safety of the Investigational products Adverse event Physical examination Biomarker of systemic safety Timepoint: Up to day 28 | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical Research Pvt Ltd
Outcome results
None listed