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Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oregano extract cream
Hydrocortisone
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Oregano, Atopic Dermatitis Quick (ADQ) score, Eczema Area and Severity Index score, Reflectance confocal microscopy

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Dermatology. Rutgers-RWJMS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard: Hydrocortisone 1% ointment

Experimental: oregano extract cream

Arm Description

Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm

Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm

Outcomes

Primary Outcome Measures

The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 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).
Change of the Clinical Efficacy Rated by a Study Physician
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).
Histological Improvement Measured by Confocal Microscopy
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.

Secondary Outcome Measures

Measure Presence of S. Aureus Colonization on Affected Skin
Bacterial culture of the affected area was done on day 0 and day 14.
Rate Cosmetic Acceptability of Topical Agents
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.
Rate Skin Tolerance of Topical Agents
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.

Full Information

First Posted
November 10, 2014
Last Updated
March 29, 2017
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT02289989
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of response to recruitment
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, Oregano, Atopic Dermatitis Quick (ADQ) score, Eczema Area and Severity Index score, Reflectance confocal microscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard: Hydrocortisone 1% ointment
Arm Type
Active Comparator
Arm Description
Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
Arm Title
Experimental: oregano extract cream
Arm Type
Experimental
Arm Description
Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
Intervention Type
Drug
Intervention Name(s)
Oregano extract cream
Other Intervention Name(s)
experimental treatment
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
active control
Intervention Description
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
Primary Outcome Measure Information:
Title
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
Description
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).
Time Frame
From baseline to day 25
Title
Change of the Clinical Efficacy Rated by a Study Physician
Description
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).
Time Frame
Baseline to day 28
Title
Histological Improvement Measured by Confocal Microscopy
Description
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.
Time Frame
Baseline to day 28
Secondary Outcome Measure Information:
Title
Measure Presence of S. Aureus Colonization on Affected Skin
Description
Bacterial culture of the affected area was done on day 0 and day 14.
Time Frame
Baseline to day 14
Title
Rate Cosmetic Acceptability of Topical Agents
Description
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.
Time Frame
On day 7 and 14
Title
Rate Skin Tolerance of Topical Agents
Description
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.
Time Frame
On day 7 and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy S Pappert, MD
Organizational Affiliation
Rutgers-RWJMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology. Rutgers-RWJMS
City
Somerset
State/Province
New Jersey
ZIP/Postal Code
08873
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

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