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Completed

NCT Number: NCT05276323

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

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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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Soroka University Medical Center

Beersheba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medihoney Derma Cream

Drug

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

Hydrocortisone 1% cream

Drug

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

Primary outcomes

  1. response rate

    Time frame: 1 month

    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)

Secondary outcomes

  1. VAS (Visual Analogue Scale) pruritis score

    Time frame: 1 month

    score range is 1 to 10. 1:no itch, 10:very itchy

  2. SCORAD - (SCORing Atopic Dermatitis)

    Time frame: 2 weeks

    SCORAD is a clinical tool used to assess the extent and severity of eczema. range 0-103. 103- worse eczema

  3. The Eczema Area and Severity Index (EASI)

    Time frame: 2 weeks

    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)

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

Medihoney® Derma Cream Treatment for Mild to Moderate Atopic Dermatitis in Children: an Open-label Randomized Pilot Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2022
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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