Atopic Dermatitis Clinical Trial
Official title:
Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: an Open-label Randomized Pilot Study
Verified date | March 2022 |
Source | Soroka University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Soroka University Medical Center | Beer Sheva |
Lead Sponsor | Collaborator |
---|---|
Soroka University Medical Center |
Israel,
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 |
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