Atopic DermatitisNCT02289989
Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis
A study testing Oregano extract cream and Hydrocortisone in people with Atopic Dermatitis, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Oregano extract cream and Hydrocortisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Dermatology. Rutgers-RWJMS
Somerset, New Jersey, 08873
About this study
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
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Oregano extract cream, Hydrocortisone
- Keywords
- Atopic dermatitis, Oregano, Atopic Dermatitis Quick (ADQ) score, Eczema Area and Severity Index score, Reflectance confocal microscopy
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oregano extract creamDrug
Also called experimental treatment
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
HydrocortisoneDrug
Also called active control
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
| Study group | Role | What they receive |
|---|---|---|
| Standard: Hydrocortisone 1% ointment | Active comparator | Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm Receives: 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 Receives: Drug: Oregano extract cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: Baseline to day 28
Secondary outcomes (3)
Measure Presence of S. Aureus Colonization on Affected Skin
Bacterial culture of the affected area was done on day 0 and day 14.
Measured: Baseline to 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.
Measured: On day 7 and 14
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.
Measured: On day 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Lack of response to recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy S Pappert, MD, Principal investigator, Rutgers-RWJMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289989
- Sponsor's protocol ID
- Pro2012002449
- Status last verified
- Jan 2017
- First submitted
- 10 Nov 2014
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02289989
- Acronym / sponsor ID
- Pro2012002449
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Oregano, Atopic Dermatitis Quick (ADQ) score, Eczema Area and Severity Index score, Reflectance confocal microscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of response to recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 13 Nov 2014 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard: Hydrocortisone 1% ointment | Active comparator | Drug: HydrocortisoneIntervention: hydrocortisone 1% ointment will be applied to one patient's forearm |
| Experimental: oregano extract cream | Experimental | Drug: Oregano extract creamIntervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oregano extract creamAlso: experimental treatmentAn 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 | Drug | Experimental: oregano extract cream |
| HydrocortisoneAlso: active controlAn 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 | Drug | Standard: Hydrocortisone 1% ointment |
Primary outcome
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).
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).
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.
3 secondary outcomes
Measure Presence of S. Aureus Colonization on Affected Skin
Time frame: Baseline to day 14
Rate Cosmetic Acceptability of Topical Agents
Time frame: On day 7 and 14
Rate Skin Tolerance of Topical Agents
Time frame: On day 7 and 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy S Pappert, MD principal investigator
Rutgers-RWJMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oregano extract cream and Hydrocortisone in people with Atopic Dermatitis, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25 (time frame: From baseline to day 25). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.