A comparative, multicenter, prospective, randomized study to evaluate efficacy, safety and prevention of relapse with Elovera AD emollient vs plain emollient in mild to moderate atopic dermatitis
Phase 4
- Conditions
- Health Condition 1: L209- Atopic dermatitis, unspecified
- Registration Number
- CTRI/2023/03/050333
- Lead Sponsor
- Glenmark Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients from 3 months-75 yrs. of age.
2. Patients who suffer from mild to moderate AD (IGA score of 2-3)
3. Patients willing to provide informed consent/parental consent/assent.
Exclusion Criteria
1. Patients not deemed fit to be prescribed topical steroids
2. Patients not deemed to be fit to be prescribed emollients
3. Patients unwilling to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Percentage of patients who achieved resolution in 4 weeks IGA score of clear or almost <br/ ><br>clear and �2-point reduction from baseline. <br/ ><br>2. Percentage of patients who suffered from relapse (Relapse is defined as recurrence of either of AD symptoms like erythema, edema, excoriation and lichenification except itching).Timepoint: Weekly, Day0, Day14(±2), Day28(±2), <br/ ><br>Every 2 weeks (telephonic) till 3 months or as and <br/ ><br>when patient experiences relapse <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Time to resolution <br/ ><br>2. Time to relapse <br/ ><br>3. Percentage of patients with eczema free after 3 months <br/ ><br>4. Percentage of patients achieving EASI clear or almost clear at end of 4 weeks <br/ ><br>5. EASI score at baseline, 2 and 4 weeks <br/ ><br>6. VAS for itching at baseline, 2 and 4 weeks <br/ ><br>7. DLQI score at baseline and 4 weeks <br/ ><br>Timepoint: At Baseline, 2 weeks and 4 weeks, Every 2 weeks till 3 months or as and when patient experiences relapse.