Status:
TERMINATED
Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-17 years
Phase:
NA
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 infla...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02289989
Start Date
November 1 2014
End Date
January 1 2017
Last Update
May 10 2017
Active Locations (1)
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1
Department of Dermatology. Rutgers-RWJMS
Somerset, New Jersey, United States, 08873