Trial Outcomes & Findings for Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis (NCT NCT02289989)
NCT ID: NCT02289989
Last Updated: 2017-05-10
Results Overview
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).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
1 participants
Primary outcome timeframe
From baseline to day 25
Results posted on
2017-05-10
Participant Flow
Recruitment was done in the department of dermatology of Rutgers-RWJMS. It was stopped in July 2016.
No exclusions or significant events were observed in the study.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
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
|
Experimental: Oregano Extract Cream
n=1 Participants
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
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to day 25This 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).
Outcome measures
| Measure |
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
|
Experimental: Oregano Extract Cream
n=1 Participants
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
|
|---|---|---|
|
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
Scaly, redness, cracks/opening day 0
|
—
|
1 participants
|
|
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
Very bothered (4) day 0
|
—
|
1 participants
|
|
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
Scaly, Redness day 25
|
—
|
1 participants
|
|
The Clinical Efficacy Rated by the Patient or Caregiver on Days 0 and 25
Quite bothered (3) day 25
|
—
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline to day 28Physician was asked to grade four characteristics: erythema, infiltration/papulation, excoriation and lichenification. The grade was none (0), mild (1), moderate (2) and severe (3).
Outcome measures
| Measure |
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
|
Experimental: Oregano Extract Cream
n=1 Participants
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
|
|---|---|---|
|
Change of the Clinical Efficacy Rated by a Study Physician
Erythema day 0 severe
|
—
|
1 participants
|
|
Change of the Clinical Efficacy Rated by a Study Physician
Infiltration/Papulation day 0 none
|
—
|
1 participants
|
|
Change of the Clinical Efficacy Rated by a Study Physician
Excoriation day 0 severe
|
—
|
1 participants
|
|
Change of the Clinical Efficacy Rated by a Study Physician
Lichenification day 0 moderate
|
—
|
1 participants
|
|
Change of the Clinical Efficacy Rated by a Study Physician
Erythema day 28 moderate
|
—
|
1 participants
|
|
Change of the Clinical Efficacy Rated by a Study Physician
Infiltration/Papulation day 28 none
|
—
|
1 participants
|
|
Change of the Clinical Efficacy Rated by a Study Physician
Excoriation day 28 mild
|
—
|
1 participants
|
|
Change of the Clinical Efficacy Rated by a Study Physician
Lichenification day 28 mild
|
—
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline to day 28Population: Data not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to day 14Bacterial culture of the affected area was done on day 0 and day 14.
Outcome measures
| Measure |
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
|
Experimental: Oregano Extract Cream
n=1 Participants
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
|
|---|---|---|
|
Measure Presence of S. Aureus Colonization on Affected Skin
Bacterial culture day 0 negative
|
—
|
1 participants
|
|
Measure Presence of S. Aureus Colonization on Affected Skin
Bacterial culture day 14 negative
|
—
|
1 participants
|
SECONDARY outcome
Timeframe: On day 7 and 14The 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.
Outcome measures
| Measure |
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
|
Experimental: Oregano Extract Cream
n=1 Participants
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
|
|---|---|---|
|
Rate Cosmetic Acceptability of Topical Agents
Cosmetic acceptability day 7 excellent
|
—
|
1 participants
|
|
Rate Cosmetic Acceptability of Topical Agents
Cosmetic acceptability day 14 excellent
|
—
|
1 participants
|
SECONDARY outcome
Timeframe: On day 7 and 14The 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.
Outcome measures
| Measure |
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
|
Experimental: Oregano Extract Cream
n=1 Participants
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
|
|---|---|---|
|
Rate Skin Tolerance of Topical Agents
Skin tolerance day 14 excellent
|
—
|
1 participants
|
|
Rate Skin Tolerance of Topical Agents
Skin tolerance day 7 excellent
|
—
|
1 participants
|
Adverse Events
Standard: Hydrocortisone 1% Ointment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental: Oregano Extract Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Amy Pappert, MD
Rutgers Robert Wood Johnson Medical School
Phone: 732-235-7765
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place