Health Condition 1: L209- Atopic dermatitis, unspecified
Conditions
Interventions
Intervention1: Eczene cream: Dosage form: Cream, Route of administration: Topical,
Dosage: Use twice a day to affected lesions located in the antecubital fossae (inner elbow areas),Duration:30 days.
C
Sponsors
Invex Health Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 65 years. 2. Mild to moderate eczema, defined as: a. Investigator s Global Assessment (IGA) score of 2 or 3 b. Eczema Area and Severity Index (EASI) score of 7 to 21 3. Presence of active eczematous lesions at baseline. 4. Willingness to sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Severe atopic dermatitis: IGA greater than or equal to 4. 2.Presence of other active inflammatory or infectious skin diseases. 3. Recent use of systemic therapy for eczema within 2 weeks. 4. Use of restricted topical eczema treatments within 2 weeks prior to baseline. 5. Known or suspected history of immunosuppression. 6. Tuberculosis or latent tuberculosis infection. 7. Positive for human immunodeficiency virus antibody, positive for syphilis specific antibody, positive for hepatitis C virus antibody or hepatitis B virus infection. 8. Pregnant or lactating women or women planning pregnancy during the study period. 9. History of skin malignancy or other serious dermatological disease or active skin disease like psoriasis or eczema. 10. Inability to adhere to protocol or unwillingness to consent for photographic documentation. 11. Any comorbidity that may interfere with assessments or pose increased risk e.g. uncontrolled systemic disease, immunosuppressive conditions or bleeding disorders. 12. Known hypersensitivity to any component in Eczene cream 13. Severe psychiatric illness affecting consent or compliance. 14. Participation in another interventional clinical trial for eczema concurrently or within last 3 months to avoid overlapping interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change from baseline in Investigator s Global Assessment (IGA) score. 2. Change from baseline in Eczema Area and Severity Index (EASI) 3. Clinical improvement through photographic appearance (Day 0 to Day 30)Timepoint: Screening visit to Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects achieving IGA success (greater than or equal to 2 point improvement) 1. Change from baseline in Pruritus Numeric Rating Scale (NRS) 3. Change from baseline in Dermatology Life Quality Index (DLQI)Timepoint: Day 0 to Day 30 | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt Ltd
Outcome results
None listed