Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

Investigator-Initiated, Randomized, Investigator-Blind, Half-Side Comparison of Topical Oregano Extract Ointment vs .Hydrocortisone 1% for the Treatment of Atopic Dermatitis in Pediatric Patients

This study is designed to evaluate and compare the efficacy of 3% oregano extract ointment prepared in aqueous solution versus 1% hydrocortisone ointment, a standard treatment, in decreasing the inflammation associated with mild to moderate atopic dermatitis. We plan to recruit 40 patients on the ages comprised between 2 and 17 years old and the study duration for each of the patient is 1 month.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Hydrocortisone; Drug: Oregano extract cream

Detailed Description

A single-center, investigator initiated, randomized controlled, double-blind trial will be conducted to determine the effects of an oregano extract in aqueous solution versus 1% hydrocortisone in the treatment of acute-subacute pediatric atopic dermatitis (AD). We suspect that topical oregano will serve as an effective, non-steroidal AD therapy, simultaneously offering extra benefits to pediatric patients as oregano is a natural product with antimicrobial, anti-inflammatory, and antiseptic properties that lacks reports of adverse effects associated with steroids, which children have been noted to be more susceptible to.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Somerset, New Jersey, United States, 08873
      • Department of Dermatology. Rutgers-RWJMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or non-pregnant female subjects aged 2-17 years of age.
• Individuals must be diagnosed with acute-subacute AD regardless of the study.
• Written informed consent must be obtained from all patients or caregivers.
• Women of childbearing potential (WOCBP) must be willing to practice effective contraception for the duration of study treatment.
• Subjects must be willing and able to comply with study conditions, properly apply or have caregivers apply topical medications to the selected body sites, as well as return to the clinic for required visits.
• Subject caregivers must be willing and able to perform ADQ assessment test.

Exclusion Criteria:

• Individuals who are immune-compromised or suffering from infectious disease, malignant disease, are known to be HIV+ or present with a general reduced level of health.
• Individuals diagnosed with underlying dermatological conditions in addition to AD.
• Individuals with a chronic pre-existing disease such as diabetes mellitus or others that in the opinion of the investigator would preclude their participation in the study.
• Individuals who are pregnant, nursing mothers, or subjects planning a pregnancy during the course of the study.
• Subjects/caregivers who are unable to communicate or comply with study conditions due to language disability, poor mental development, or impaired cerebral function.
• Individuals who are simultaneously enrolled in another clinical drug or device research study.
• Individuals with a history of chronic steroid use.
• Individuals needing to concurrently use topical agents, medicinal products containing corticosteroids, or immunosuppressants.
• Individuals who have received systemically administered corticosteroids and/or antihistamines 2 weeks prior to the start of study.
• Individuals undergoing light therapy.
• Individuals who have been treated with another investigation device or drug within 30 days prior to study enrollment.
• Individuals with a known allergy to oregano.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard: Hydrocortisone 1% ointment; Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm	Drug: Hydrocortisone; An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment; Other Names: active control
Experimental: Experimental: oregano extract cream; Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm	Drug: Oregano extract cream; An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment; Other Names: experimental treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25	This was measured with two questions. The first one referred to the description of the lesion and it included six characteristics: clear, dry, scaly, redness, cracks/opening and oozing. The second questions asked to grade how itchy was the patient. All characteristics were measured on a scale from 0 to 5 (0 none, 5 extremely bothered/losing sleep).	From baseline to day 25
Change of the Clinical Efficacy Rated by a Study Physician	Physician was asked to grade four characteristics: erythema, infiltration/papulation, excoriation and lichenification. The grade was none (0), mild (1), moderate (2) and severe (3).	Baseline to day 28
Histological Improvement Measured by Confocal Microscopy	Confocal microscopy was done to the patient on day 0, day 14 and day 28. Due to technical difficulties, this outcome measure was not collected.	Baseline to day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure Presence of S. Aureus Colonization on Affected Skin	Bacterial culture of the affected area was done on day 0 and day 14.	Baseline to day 14
Rate Cosmetic Acceptability of Topical Agents	The patient or caregiver rated how the product felt on their skin after applying the product, measuring the cosmetic acceptability on day 7 and 14. The scale was excellent, good, moderate and poor.	On day 7 and 14
Rate Skin Tolerance of Topical Agents	The patient or caregiver rated how well the patient tolerated the product after applying it on day 7 and 14. The scale was excellent, good, moderate and poor.	On day 7 and 14

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Amy S Pappert, MD, Rutgers-RWJMS

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 10, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Atopic dermatitis; Oregano; Atopic Dermatitis Quick (ADQ) score; Eczema Area and Severity Index score; Reflectance confocal microscopy
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: Pro2012002449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided