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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medihoney Derma Cream | Drug | applied topically, twice a day, on all affected areas in the body for two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| VAS (Visual Analogue Scale) pruritis score | score range is 1 to 10. 1:no itch, 10:very itchy | 1 month |
| SCORAD - (SCORing Atopic Dermatitis) | SCORAD is a clinical tool used to assess the extent and severity of eczema. range 0-103. 103- worse eczema |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka University Medical Center | Beersheba | Israel |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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.
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| Hydrocortisone 1% cream | Drug | applied topically, twice a day, on all affected areas in the body for two weeks. |
|
| 2 weeks |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |