Clinical trial NCT02289989: Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Oregano
Atopic Dermatitis Quick (ADQ) score
Eczema Area and Severity Index score
Reflectance confocal microscopy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 1
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
timeFrame: From baseline to day 25
measure: Change of the Clinical Efficacy Rated by a Study Physician
timeFrame: Baseline to day 28
measure: Histological Improvement Measured by Confocal Microscopy
timeFrame: Baseline to day 28
Secondary outcomes:
measure: Measure Presence of S. Aureus Colonization on Affected Skin
timeFrame: Baseline to day 14
measure: Rate Cosmetic Acceptability of Topical Agents
timeFrame: On day 7 and 14
measure: Rate Skin Tolerance of Topical Agents
timeFrame: On day 7 and 14
Other outcomes:
Locations:
city: Somerset
country: United States
facility: Department of Dermatology. Rutgers-RWJMS
state: New Jersey
Study officials:
affiliation: Rutgers-RWJMS
name: Amy S Pappert, MD
role: PRINCIPAL_INVESTIGATOR
References: