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

NCT05276323 | Completed Phase 2

• 1 other identifier: SorokaUMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

eczema; atopic dermatitis; Medihoney dermacream

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• VAS (Visual Analogue Scale) pruritis score

  1 month

• SCORAD - (SCORing Atopic Dermatitis)

  2 weeks

• The Eczema Area and Severity Index (EASI)

  2 weeks

Study Arms (2)

Medihoney Derma Cream

EXPERIMENTAL

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

Hydrocortisone 1% cream

ACTIVE COMPARATOR

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

Interventions

Medihoney Derma Cream DRUG

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

Medihoney Derma Cream

Hydrocortisone 1% cream DRUG

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

Hydrocortisone 1% cream

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• mild to moderate atopic dermatitis
• an IGA score of 2-3
• BSA score of 1%-10%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pediatric dermatology

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 11, 2022
• Study Start: October 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: December 31, 2021
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)