Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

NCT ID: NCT02289989

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2017-01-31

Brief Summary

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.

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Standard: Hydrocortisone 1% ointment

Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm

Group Type: ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type: DRUG

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

Experimental: oregano extract cream

Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm

Group Type: EXPERIMENTAL

Oregano extract cream

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

experimental treatment; active control

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy S Pappert, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers-RWJMS

Locations

Department of Dermatology. Rutgers-RWJMS

Somerset, New Jersey, United States

Countries

United States

Other Identifiers

Pro2012002449

Identifier Type: -

Identifier Source: org_study_id