Trial Outcomes & Findings for Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis (NCT NCT02227836)
NCT ID: NCT02227836
Last Updated: 2019-04-17
Results Overview
Sensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
up to 120 hours after application of patch test
Results posted on
2019-04-17
Participant Flow
Participant milestones
| Measure |
Allergy Patch Testing APT
Patient will undergo Atopy Patch Testing (APT) per the following protocol:
* 2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.
* Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits
* The patches will be removed at 48 hours, and results read at 72 and 120 hours after application.
* Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).
|
|---|---|
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Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Allergy Patch Testing APT
n=8 Participants
Patient will undergo APT testing per the following protocol:
* 2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.
* Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits
* The patches will be removed at 48 hours, and results read at 72 and 120 hours after application.
* Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).
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|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 11 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
|
Allergic history
|
7 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 120 hours after application of patch testSensitivity of the patch test will be defined by the number of subjects with total positive APT reactions correlated to histologic findings
Outcome measures
| Measure |
Allergy Patch Testing APT
n=8 Participants
Patient will undergo APT testing per the following protocol:
* 2g of dry foods will be placed in 2ml of isotonic saline solution. The mixtures will then be placed in aluminum cups (ie Finn chambers) measuring 6 or 12 mm in diameter and adhered to the patient's back.
* Foods to be included will be milk, wheat, egg, soy, peanut, tree nut, fish, shellfish, beef, corn, chicken, potato, pork, legumes, barley, rye, tomato, rice, fruits
* The patches will be removed at 48 hours, and results read at 72 hours after application.
* Reactions will be classified as negative, + (erythema and scattered papules), ++ (erythema and papules), and +++ (erythema and vesicles).
|
|---|---|
|
Sensitivity of Patch Testing
|
1 Participants
|
Adverse Events
Allergy Patch Testing APT
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place