Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

March 29, 2017 updated by: Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Somerset, New Jersey, United States, 08873
        • Department of Dermatology. Rutgers-RWJMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard: Hydrocortisone 1% ointment
Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
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
Other Names:
  • active control
Experimental: Experimental: oregano extract cream
Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
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
Other Names:
  • experimental treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
Time Frame: From baseline to day 25

This was measured with two questions. The first one referred to the description of the lesion and it included six characteristics: clear, dry, scaly, redness, cracks/opening and oozing. The second questions asked to grade how itchy was the patient.

All characteristics were measured on a scale from 0 to 5 (0 none, 5 extremely bothered/losing sleep).
From baseline to day 25
Change of the Clinical Efficacy Rated by a Study Physician
Time Frame: Baseline to day 28
Physician was asked to grade four characteristics: erythema, infiltration/papulation, excoriation and lichenification. The grade was none (0), mild (1), moderate (2) and severe (3).
Baseline to day 28
Histological Improvement Measured by Confocal Microscopy
Time Frame: Baseline to day 28
Confocal microscopy was done to the patient on day 0, day 14 and day 28. Due to technical difficulties, this outcome measure was not collected.
Baseline to day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure Presence of S. Aureus Colonization on Affected Skin
Time Frame: Baseline to day 14
Bacterial culture of the affected area was done on day 0 and day 14.
Baseline to day 14
Rate Cosmetic Acceptability of Topical Agents
Time Frame: On day 7 and 14
The patient or caregiver rated how the product felt on their skin after applying the product, measuring the cosmetic acceptability on day 7 and 14. The scale was excellent, good, moderate and poor.
On day 7 and 14
Rate Skin Tolerance of Topical Agents
Time Frame: On day 7 and 14
The patient or caregiver rated how well the patient tolerated the product after applying it on day 7 and 14. The scale was excellent, good, moderate and poor.
On day 7 and 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amy S Pappert, MD, Rutgers-Rwjms

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro2012002449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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