Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02289989
• Other study ID #: Pro2012002449
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2014
• Last updated: December 17, 2015
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: Rutgers, The State University of New Jersey
• Contact: Lilia M Correa, MD
• Phone: 732-235-6996
• Email: lilia.correa[@]rutgers.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Department of Dermatology. Rutgers-RWJMS	Somerset	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the clinical efficacy rated by the patient or caregiver		From baseline to day 25	No
Primary	Change of the clinical efficacy rated by a study physician		Baseline to day 25	No
Primary	Change of the clinical efficacy rated by a study physician		Baseline to day 28	No
Primary	Histological improvement measured by confocal microscopy		Baseline to day 28	No
Secondary	Measure presence of S. aureus colonization on affected skin		Baseline to day 14	No
Secondary	Rate cosmetic acceptability of topical agents		On day 7	No
Secondary	Rate cosmetic acceptability of topical agents		On day 14	Yes
Secondary	Rate skin tolerance of topical agents		On day 7	No
Secondary	Rate skin tolerance of topical agents		On day 14	No