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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050333

Enrollment

160

Registered

2023-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L209- Atopic dermatitis, unspecified

Interventions

Intervention1: Elovera AD emollient: Subject will receive topical corticosteroid (desonide cream 0.05%) and Elovera AD emollient twice daily for 4 weeks. Control Intervention1: Desonide cream 0.05% an

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Percentage of patients who achieved resolution in 4 weeks IGA score of clear or almost clear and â?¥2-point reduction from baseline. 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(Â±2), Day28(Â±2), Every 2 weeks (telephonic) till 3 months or as and when patient experiences relapse	—

Measure

Time frame

1. Percentage of patients who achieved resolution in 4 weeks IGA score of clear or almost clear and â?¥2-point reduction from baseline. 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(Â±2), Day28(Â±2), Every 2 weeks (telephonic) till 3 months or as and when patient experiences relapse

—

Secondary

Measure	Time frame
1. Time to resolution 2. Time to relapse 3. Percentage of patients with eczema free after 3 months 4. Percentage of patients achieving EASI clear or almost clear at end of 4 weeks 5. EASI score at baseline, 2 and 4 weeks 6. VAS for itching at baseline, 2 and 4 weeks 7. DLQI score at baseline and 4 weeks Timepoint: At Baseline, 2 weeks and 4 weeks, Every 2 weeks till 3 months or as and when patient experiences relapse.	—

Measure

Time frame

1. Time to resolution 2. Time to relapse 3. Percentage of patients with eczema free after 3 months 4. Percentage of patients achieving EASI clear or almost clear at end of 4 weeks 5. EASI score at baseline, 2 and 4 weeks 6. VAS for itching at baseline, 2 and 4 weeks 7. DLQI score at baseline and 4 weeks Timepoint: At Baseline, 2 weeks and 4 weeks, Every 2 weeks till 3 months or as and when patient experiences relapse.

—

Countries

India

Contacts

Public ContactMr Swapan Biswas

Infoclin LLP

swapan@infoclinconsultancy.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026