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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05276323
Other study ID # SorokaUMC
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Medihoney Derma Cream
applied topically, twice a day, on all affected areas in the body for two weeks.
Hydrocortisone 1% cream
applied topically, twice a day, on all affected areas in the body for two weeks.

Locations

Country Name City State
Israel Soroka University Medical Center Beer Sheva

Sponsors (1)

Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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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