Health Condition 1: L20-L30- Dermatitis and eczema
Conditions
Interventions
Intervention1: Zipitrit Skin Cream: Apply sufficient amount of cream twice daily on the affected area (Use mild soap for cleansing the skin before applying the cream) for 28 Days
Control Intervention1
Sponsors
M. N. Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age group between 18 to 65 years old, both inclusive 2. Confirmed diagnosis of skin fungal infection 3. No systemic antifungal treatment within the previous two weeks 4. No use of topical antifungal agents within the previous seven days 5. No history of allergy to components of the study medication 6. Subjects ready to take injection TT before application of study drug Inclusion criteria for eczema: 1. Patients of either sex in the age group between 18 to 65 years both inclusive; 2. IGA score of 2 or 3 (mild or moderate) during screening and baseline; 3. BSA of AD involvement of 4-12%; 4. EASI of 5-20 Clinical diagnoses of Atopic Dermatitis (as defined by Hanifin and Rajka criteria); 5. Atopic Dermatitis should be present for at least three months with stable disease for more than or equal to 1 month prior to screening. 6. Subjects ready to take injection TT before application of study drug
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women or women of child bearing positive urine pregnancy test at screening. All subjects agree to use an adequate contraceptive method throughout the study; 2. Use of biologic therapy within 12 weeks; 3. Regular use of tanning booth within 4 weeks; 4. Concomitant dermatologic (e.g. irritant contact dermatitis, allergic contact dermatitis, psoriasis, etc.) or other medical condition(s) which may interfere with study assessments; 5. Any other comorbid condition which is not on stable prescription for last 3 months. 6. Subjects who are using any concomitant medications that in the investigators opinion, could affect the subjects atopic dermatitis (e.g. Antihistamines) Subjects using such medications and have been stable on treatment for at least one month prior to visit 2 (Day 1 of IP) and no changes to these medications are planned during study may be included in the study at the investigators discretion; 7. Abnormal renal function (defined as serum creatinine more than 1.5xULN) or abnormal liver function (defined as any transaminases more than 2xULN); 8. Known hypersensitivity to any of the components of the study drug; 9. Known or suspected history of alcohol or drug abuse; 10. Subjects with a history of human immunodeficiency virus (HIV) as determined by medical history; 11. Subjects who are receiving any investigational drug or who participated in a similar clinical trial with an investigational product within the last 3 months; 12. Any other condition as per discretion of investigator would interfere with the clinical evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To treat skin fungal infections and assess the time required (in days) for complete healing and symptom resolution. 2.Eczema Area and Severity Index (EASI) EASI assesses the extent and severity of atopic dermatitis. EASI is a composite index with scores ranging from 0 to 72. Higher values indicate more severe or extensive disease. Timepoint: From baseline to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of the extent of fungal infection, including surface area coverage and severity of symptoms such as redness itching and scaling. 2. Evaluation of treatment efficacy by monitoring the reduction in fungal growth and improvement in skin appearance including texture color and presence of lesions or rash. 3.Investigator Global Assessment(IGA) The IGA assesses the overall appearance and severity of atopic dermatitis using a 5-point scale [0 (clear) to 4 (severe)] 4.Body Surface Area (BSA) BSA estimates the extent of atopic dermatitis involvement and is expressed as a percentage of total body surface area. 5. Pruritus-NRS The pruritus NRS is an 11-point scale used by subjects to rate their worst itch severity over the past 24 hours with 0 indicating no itch and 10 indicating worst itch imaginable. 6. Quality of life at baseline and end of the study by using dermatology life quality index DLQI questionnaire Timepoint: From baseline to Day 28 | — |
Countries
India
Contacts
Public ContactMr Ashish Nagaonkar
Mprex Healthcare Pvt Ltd
Outcome results
None listed