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

Soroka University Medical Center

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Medihoney Derma Cream; Drug: Hydrocortisone 1% cream

Study type: Interventional

Funder types: Other

Identifiers

NCT05276323

SorokaUMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Medihoney Derma Cream

Experimental group

Description:

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.

Treatment:

Drug: Medihoney Derma Cream

Hydrocortisone 1% cream

Active Comparator group

Description:

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.

Treatment:

Drug: Hydrocortisone 1% cream