Back to resultsMedihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Medihoney Derma Cream
Hydrocortisone 1% cream
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, atopic dermatitis, Medihoney dermacream
Eligibility Criteria
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
Sites / Locations
- Soroka University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Medihoney Derma Cream
Hydrocortisone 1% cream
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
VAS (Visual Analogue Scale) pruritis score
score range is 1 to 10. 1:no itch, 10:very itchy
SCORAD - (SCORing Atopic Dermatitis)
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)
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)
Full Information
NCT ID
NCT05276323
First Posted
February 20, 2022
Last Updated
March 2, 2022
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05276323
Brief Title
Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study
Official Title
Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: an Open-label Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema, atopic dermatitis, Medihoney dermacream
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medihoney Derma Cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Hydrocortisone 1% cream
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Medihoney Derma Cream
Intervention Description
applied topically, twice a day, on all affected areas in the body for two weeks.
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone 1% cream
Intervention Description
applied topically, twice a day, on all affected areas in the body for two weeks.
Primary Outcome Measure Information:
Title
response rate
Description
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 Outcome Measure Information:
Title
VAS (Visual Analogue Scale) pruritis score
Description
score range is 1 to 10. 1:no itch, 10:very itchy
Time Frame
1 month
Title
SCORAD - (SCORing Atopic Dermatitis)
Description
SCORAD is a clinical tool used to assess the extent and severity of eczema. range 0-103. 103- worse eczema
Time Frame
2 weeks
Title
The Eczema Area and Severity Index (EASI)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Soroka University Medical Center
City
Beer Sheva
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study
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