Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis, Oregano, Atopic Dermatitis Quick (ADQ) score, Eczema Area and Severity Index score, Reflectance confocal microscopy
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.
Interventions
DRUGOregano 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
DRUGHydrocortisone
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
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Measure Presence of S. Aureus Colonization on Affected Skin | Baseline to day 14 | Bacterial culture of the affected area was done on day 0 and day 14. |
| Rate Cosmetic Acceptability of Topical Agents | 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. |
| Rate Skin Tolerance of Topical Agents | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment was done in the department of dermatology of Rutgers-RWJMS. It was stopped in July 2016.
Pre-assignment details
No exclusions or significant events were observed in the study.
Participants by arm
| Arm | Count |
|---|---|
| Standard: Hydrocortisone 1% Ointment Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm
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 | 0 |
| Experimental: Oregano Extract Cream Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm
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 | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Experimental: Oregano Extract Cream | Total |
|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
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).
Time frame: Baseline to day 28
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Oregano Extract Cream | Change of the Clinical Efficacy Rated by a Study Physician | Erythema day 0 severe | 1 participants |
| Experimental: Oregano Extract Cream | Change of the Clinical Efficacy Rated by a Study Physician | Lichenification day 0 moderate | 1 participants |
| Experimental: Oregano Extract Cream | Change of the Clinical Efficacy Rated by a Study Physician | Erythema day 28 moderate | 1 participants |
| Experimental: Oregano Extract Cream | Change of the Clinical Efficacy Rated by a Study Physician | Infiltration/Papulation day 28 none | 1 participants |
| Experimental: Oregano Extract Cream | Change of the Clinical Efficacy Rated by a Study Physician | Excoriation day 28 mild | 1 participants |
| Experimental: Oregano Extract Cream | Change of the Clinical Efficacy Rated by a Study Physician | Lichenification day 28 mild | 1 participants |
| Experimental: Oregano Extract Cream | Change of the Clinical Efficacy Rated by a Study Physician | Infiltration/Papulation day 0 none | 1 participants |
| Experimental: Oregano Extract Cream | Change of the Clinical Efficacy Rated by a Study Physician | Excoriation day 0 severe | 1 participants |
Primary
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.
Time frame: Baseline to day 28
Population: Data not collected
Primary
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).
Time frame: From baseline to day 25
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Oregano Extract Cream | The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25 | Scaly, redness, cracks/opening day 0 | 1 participants |
| Experimental: Oregano Extract Cream | The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25 | Very bothered (4) day 0 | 1 participants |
| Experimental: Oregano Extract Cream | The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25 | Scaly, Redness day 25 | 1 participants |
| Experimental: Oregano Extract Cream | The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25 | Quite bothered (3) day 25 | 1 participants |
Secondary
Measure Presence of S. Aureus Colonization on Affected Skin
Bacterial culture of the affected area was done on day 0 and day 14.
Time frame: Baseline to day 14
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Oregano Extract Cream | Measure Presence of S. Aureus Colonization on Affected Skin | Bacterial culture day 0 negative | 1 participants |
| Experimental: Oregano Extract Cream | Measure Presence of S. Aureus Colonization on Affected Skin | Bacterial culture day 14 negative | 1 participants |
Secondary
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.
Time frame: On day 7 and 14
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Oregano Extract Cream | Rate Cosmetic Acceptability of Topical Agents | Cosmetic acceptability day 7 excellent | 1 participants |
| Experimental: Oregano Extract Cream | Rate Cosmetic Acceptability of Topical Agents | Cosmetic acceptability day 14 excellent | 1 participants |
Secondary
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.
Time frame: On day 7 and 14
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Experimental: Oregano Extract Cream | Rate Skin Tolerance of Topical Agents | Skin tolerance day 7 excellent | 1 participants |
| Experimental: Oregano Extract Cream | Rate Skin Tolerance of Topical Agents | Skin tolerance day 14 excellent | 1 participants |