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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Medihoney Derma Cream; Drug: Hydrocortisone 1% cream

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Beer Sheva, Israel
    • Soroka University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medihoney Derma Cream; 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; applied topically, twice a day, on all affected areas in the body for two weeks.
Active Comparator: Hydrocortisone 1% cream; 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; applied topically, twice a day, on all affected areas in the body for two weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 20, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema; Medihoney dermacream
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: SorokaUMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No