Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

NCT02289989 | Terminated Results

• 1 other identifier: Pro2012002449
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Oregano; Atopic Dermatitis Quick (ADQ) score; Eczema Area and Severity Index score; Reflectance confocal microscopy

Outcome Measures

Primary Outcomes (3)

• 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).

  From baseline to day 25

• 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).

  Baseline to day 28

• 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.

  Baseline to day 28

Secondary Outcomes (3)

• Measure Presence of S. Aureus Colonization on Affected Skin

  Baseline to day 14

• Rate Cosmetic Acceptability of Topical Agents

  On day 7 and 14

• Rate Skin Tolerance of Topical Agents

  On day 7 and 14

Study Arms (2)

Standard: Hydrocortisone 1% ointment

ACTIVE COMPARATOR

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

Drug: Hydrocortisone

Experimental: oregano extract cream

EXPERIMENTAL

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

Drug: Oregano extract cream

Interventions

Oregano extract cream DRUG

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

Also known as: experimental treatment

Experimental: oregano extract cream

Hydrocortisone DRUG

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

Also known as: active control

Standard: Hydrocortisone 1% ointment

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Department of Dermatology. Rutgers-RWJMS

Somerset, New Jersey, 08873, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Limitations and Caveats

Termination of the trial due to difficulty recruiting patients.

Results Point of Contact

• Title: Amy Pappert, MD
• Organization: Rutgers Robert Wood Johnson Medical School

papperas@rwjms.rutgers.edu

732-235-7765

Study Officials

• Amy S Pappert, MD

  Rutgers-RWJMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 13, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-01

Locations

US (1)