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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Medihoney Derma Cream; Drug: Hydrocortisone 1% cream

• Registration Number: NCT05276323
• Lead Sponsor: Soroka University Medical Center

Brief Summary

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

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 Timeline

• Study Start: 2020-10-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-12-31
• Study First Submitted: 2022-02-20
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-11
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Medihoney Derma Cream	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.
Hydrocortisone 1% cream	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.

Primary Outcome Measures

Name	Time	Method
response rate	1 month	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)

Secondary Outcome Measures

Name	Time	Method
SCORAD - (SCORing Atopic Dermatitis)	2 weeks	SCORAD is a clinical tool used to assess the extent and severity of eczema. range 0-103. 103- worse eczema
The Eczema Area and Severity Index (EASI)	2 weeks	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)
VAS (Visual Analogue Scale) pruritis score	1 month	score range is 1 to 10. 1:no itch, 10:very itchy

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel