Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study

Study Overview
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Brief Summary
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A randomized, open-label trial comparing Medihoney Derma Cream to Hydrocortisone 1% cream. Children between the ages of 2-18 years old diagnosed with mild to moderate atopic dermatitis with an IGA (Investigator Global Assessment) score of 2-3, and a BSA (Body Surface Area) score of 1%-10% were included.

Detailed Description
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A randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses and pruritus change.

Official Title
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Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: an Open-label Randomized Pilot Study

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Medihoney Derma Cream
* Drug: Hydrocortisone 1% cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 2-18 years old mild to moderate atopic dermatitis an IGA score of 2-3 BSA score of 1%-10%. Exclusion Criteria: participation in any clinical trial less than 28 days before the enrollment AD-related systemic therapy or phototherapy within 28 days prior to the enrollment topical corticosteroids, calcineurin inhibitors, or PDE4 inhibitors use within 7 days prior to the enrollment

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: We conducted a randomized trial comprising children aged 2-18 diagnosed with mild to moderate AD, with an IGA of 2-3 and BSA of 1%-10%, including 30 patients, 20 using Med-D-Cream and 10 as controls using Hydrocortisone 1% cream. Patients applied creams for 2 weeks and were then followed for two weeks to measure clinical responses.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medihoney Derma Cream<br>Intervention group: Medihoney Derma Cream will be applied topically, twice a day, on all affected areas in the body for two weeks. Then, follow-up for two more weeks, overall participating for 4 weeks in the trial. | Drug: Medihoney Derma Cream<br>* applied topically, twice a day, on all affected areas in the body for two weeks.<br>|
| Active Comparator: Hydrocortisone 1% cream<br>control group: Hydrocortisone 1% cream will be applied topically, twice a day, on all affected areas in the body for two weeks. Then, follow-up for two more weeks, overall participating for 4 weeks in the trial. | Drug: Hydrocortisone 1% cream<br>* applied topically, twice a day, on all affected areas in the body for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | This study's primary outcome was defined as an IGA (Investigator Global Assessment) severity score of 0 or 1 with at least 1-grade reduction at visit 3. score range 0-4 (4 worse symptomes) | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (Visual Analogue Scale) pruritis score | score range is 1 to 10. 1:no itch, 10:very itchy | 1 month | 
| SCORAD - (SCORing Atopic Dermatitis) | SCORAD is a clinical tool used to assess the extent and severity of eczema. range 0-103. 103- worse eczema | 2 weeks | 
| The Eczema Area and Severity Index (EASI) | is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. The minimum EASI score is 0 and the maximum EASI score is 72 (72 worse eczema) | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eczema, atopic dermatitis, Medihoney dermacream