Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis
| Status: | Recruiting |
|---|---|
| Conditions: | Psoriasis, Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 4/21/2016 |
| Start Date: | November 2014 |
| End Date: | June 2016 |
| Contact: | Lilia M Correa, MD |
| Email: | lilia.correa@rutgers.edu |
| Phone: | 732-235-6996 |
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.
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.
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 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.
conducted to determine the effects of an oregano extract in aqueous solution versus 1%
hydrocortisone in the treatment of acute-subacute pediatric 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.
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.
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