Health Condition 1: L80-L99- Other disorders of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Tubby: Tubby nutririch lotion is an emollient for dry skin
The lotion is to be applied gently all over the body to severely dry areas, in the morning & in the evening before retiring t
Sponsors
Sante Mernaud Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Children between 6 months to 12 years of age • Parents willing to provide written informed consent/assent • Diagnosed as having dry skin with or without mild to moderate atopic tendency
Exclusion criteria
Exclusion criteria: • Patient has clinically infected atopic dermatitis at baseline. • Patient with known hypersensitivity in general, to study drug or any excipients of the product • Any dermatological condition other than atopic dermatitis that in the Investigators opinion may interfere with the evaluation of the patients atopic dermatitis • Patients using non-sedating histamines least 7 days prior to the first dosing day or throughout the study. • Severe Atopic Dermatitis • History of other skin disorders, that could interfere with the evaluations • Use of any topical treatment known or suspected to have an effect on atopic dermatitis within one week prior to the screen visit (except for calcineurin inhibitors, for which the washout is 2 weeks) • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study • Use of any other investigational agent in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Change from Baseline in the EASI (Eczema Area Severity Index) Score [All visits]. â?¢ Investigator global evaluation [Base line and Week 4] â?¢ Change in Moisture content and trans-epidermal water loss from baseline [Base line and Week 4] Timepoint: Base line and Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Quality of life by using IDQOL and DFI, CDQOL [Base line and Week 4] â?¢ Investigator/Patient LAR/patient evaluation (All visits) for Comedogenic, Photosensitivity and hypoallergenicity â?¢ To monitor the Adverse events and concomitant medications in all visitsTimepoint: Base line and Week 4 | — |
Countries
India
Contacts
Public ContactVikram Baburao
Sante Mernaud Pharmaceuticals
Outcome results
None listed