Not provided
Not provided
Not provided
Not provided
Not provided
Lack of response to recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard: Hydrocortisone 1% ointment | Active Comparator | Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm |
|
| Experimental: oregano extract cream | Experimental | Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Presence of S. Aureus Colonization on Affected Skin | Bacterial culture of the affected area was done on day 0 and day 14. | Baseline to day 14 |
| Rate Cosmetic Acceptability of Topical Agents |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amy S Pappert, MD | Rutgers-RWJMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology. Rutgers-RWJMS | Somerset | New Jersey | 08873 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
No exclusions or significant events were observed in the study.
Recruitment was done in the department of dermatology of Rutgers-RWJMS. It was stopped in July 2016.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | participants | From baseline to day 25 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Termination of the trial due to difficulty recruiting patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Pappert, MD | Rutgers Robert Wood Johnson Medical School | 732-235-7765 | papperas@rwjms.rutgers.edu |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
|
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.
| 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. | On day 7 and 14 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 |
|
|
| 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). | Posted | Number | participants | Baseline to day 28 |
|
|
|
| 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. | Data not collected | Posted | Baseline to day 28 |
|
|
| Secondary | Measure Presence of S. Aureus Colonization on Affected Skin | Bacterial culture of the affected area was done on day 0 and day 14. | Posted | Number | participants | Baseline to day 14 |
|
|
|
| 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. | Posted | Number | participants | On day 7 and 14 |
|
|
|
| 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. | Posted | Number | participants | On day 7 and 14 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| Title | Measurements |
|---|---|
|
| Lichenification day 0 moderate |
|
| Erythema day 28 moderate |
|
| Infiltration/Papulation day 28 none |
|
| Excoriation day 28 mild |
|
| Lichenification day 28 mild |
|