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Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atopic Dermatitis

Intervention: Oregano extract cream (Drug); Hydrocortisone (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Rutgers, The State University of New Jersey

Official(s) and/or principal investigator(s):
Amy S Pappert, MD, Principal Investigator, Affiliation: Rutgers-RWJMS

Overall contact:
Lilia M Correa, MD, Phone: 732-235-6996, Email: lilia.correa@rutgers.edu

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change of the clinical efficacy rated by the patient or caregiver

Change of the clinical efficacy rated by a study physician

Change of the clinical efficacy rated by a study physician

Histological improvement measured by confocal microscopy

Secondary outcome:

Measure presence of S. aureus colonization on affected skin

Rate cosmetic acceptability of topical agents

Rate cosmetic acceptability of topical agents

Rate skin tolerance of topical agents

Rate skin tolerance of topical agents

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 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.

Eligibility

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

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 medicationsto 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.

Locations and Contacts

Lilia M Correa, MD, Phone: 732-235-6996, Email: lilia.correa@rutgers.edu

Department of Dermatology. Rutgers-RWJMS, Somerset, New Jersey 08873, United States; Recruiting
Lilia M Correa, MD, Phone: 732-235-6996, Email: lilia.correa@rutgers.edu
Additional Information

Starting date: November 2014
Last updated: November 10, 2014

Page last updated: August 23, 2015

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