Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Medihoney Derma Cream

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.

Group Type EXPERIMENTAL

Medihoney Derma Cream

Intervention Type DRUG

applied topically, twice a day, on all affected areas in the body for two weeks.

Hydrocortisone 1% cream

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.

Group Type ACTIVE_COMPARATOR

Hydrocortisone 1% cream

Intervention Type DRUG

applied topically, twice a day, on all affected areas in the body for two weeks.

Interventions

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Medihoney Derma Cream

applied topically, twice a day, on all affected areas in the body for two weeks.

Intervention Type DRUG

Hydrocortisone 1% cream

applied topically, twice a day, on all affected areas in the body for two weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes