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

Soroka University Medical Center30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Medihoney Derma CreamDRUG

applied topically, twice a day, on all affected areas in the body for two weeks.

Hydrocortisone 1% creamDRUG

applied topically, twice a day, on all affected areas in the body for two weeks.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Soroka University Medical Center

Beersheba, Israel

Outcomes

Primary Outcomes

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)

Time frame: 1 month

Secondary Outcomes

VAS (Visual Analogue Scale) pruritis score

score range is 1 to 10. 1:no itch, 10:very itchy

Time frame: 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

Time frame: 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)

Time frame: 2 weeks

Data from ClinicalTrials.gov

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