Atopic Dermatitis
Conditions
Keywords
eczema, atopic dermatitis, Medihoney dermacream
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.
Interventions
DRUGMedihoney Derma Cream
applied topically, twice a day, on all affected areas in the body for two weeks.
applied topically, twice a day, on all affected areas in the body for two weeks.
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| VAS (Visual Analogue Scale) pruritis score | 1 month | score range is 1 to 10. 1:no itch, 10:very itchy |
| 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) |
Countries
Israel
Outcome results
None listed