Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02289989
Recruitment Status : Terminated (Lack of response to recruitment)
First Posted : November 13, 2014
Results First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Oregano extract cream Drug: Hydrocortisone Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Arm Intervention/treatment
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 Name: 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 Name: experimental treatment




Primary Outcome Measures :
  1. 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).


  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289989


Locations
Layout table for location information
United States, New Jersey
Department of Dermatology. Rutgers-RWJMS
Somerset, New Jersey, United States, 08873
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Layout table for investigator information
Principal Investigator: Amy S Pappert, MD Rutgers-RWJMS

Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02289989     History of Changes
Other Study ID Numbers: Pro2012002449
First Posted: November 13, 2014    Key Record Dates
Results First Posted: May 10, 2017
Last Update Posted: May 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rutgers, The State University of New Jersey:
Atopic dermatitis
Oregano
Atopic Dermatitis Quick (ADQ) score
Eczema Area and Severity Index score
Reflectance confocal microscopy

Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents