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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05276323
• Other study ID #: SorokaUMC
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Medihoney Derma Cream
applied topically, twice a day, on all affected areas in the body for two weeks.
• Hydrocortisone 1% cream
applied topically, twice a day, on all affected areas in the body for two weeks.

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	VAS (Visual Analogue Scale) pruritis score	score range is 1 to 10. 1:no itch, 10:very itchy	1 month
Secondary	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
Secondary	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