Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03968562 |
| Other study ID # |
1349966 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2019 |
| Est. completion date |
May 14, 2022 |
Study information
| Verified date |
October 2021 |
| Source |
State University of New York - Downstate Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Investigators will study the effects of topical doxycycline on cutaneous allergic early and
late phase responses by determining allergen skin responses in each subject after a single
application to allergen induced allergic swelling of 2% doxycycline in emollient.
Description:
This study is a cross-sectional survey to be completed in a single consecutive two day study
visit.
To assess the effect of topical doxycycline 2% emollient cream or control emollient on
immediate hypersensitivity allergy skin tests responses, pruritus, and associated late phase
skin swelling.
Investigators will use generic Aquaphor, a skin protectant, as the control emollient. The
active ingredient in this cream is Petrolatum 42%. Inactive ingredients include ceresin,
lanolin alcohol, microcrystalline wax, mineral oil, phenoxyethanol.
Adults (ages 18-75 yrs) treated at the SUNY Downstate/UHB Allergy Faculty Practice with known
respiratory (allergic rhinoconjunctivitis and/or asthma), and who have previously been
evaluated and are allergen skin prick test (SPT) positive to common aeroallergens will, after
five days of non-use of oral antihistamine therapy, undergo limited repeat SPT with the same
documented positive allergens (up to 5 allergens per subject).
1. Allergen skin prick testing (Dermapik method) will be done on the volar surface of each
forearm, with identical SPT allergens. The profile to be tested will be individualized,
from 1-5- allergens, to be determined by previous skin test positive results. Volunteers
for the study who have not been previously tested will also be eligible, provided they
have a history of symptoms consistent with allergic rhinoconjunctivitis and/or asthma.
These subjects will receive testing with a select panel of 5 mixed allergens - to
include both perennial (cat, dust mite) and seasonal (tree, grass, ragweed).
Each subject will also be tested with standardized negative and positive controls of
saline and histamine. Two control sites, left and right mid upper back, will both be
pricked with histamine and saline.
2. After 20 minutes, the initial baseline determination of mean diameter (average of widest
and its orthogonal measurement) will be taken of both wheal and flare, as will itch
scores for each arm and each back control site (VAS (0 to 100 mm line) and verbal rating
scale ( 0 - none, 1 - mild, 2 - moderate, 4 - severe)).
3. The location (right versus left) of placement of medication (active) versus control will
be determined by a random numbers list for both forearm and back evaluation test sites.
The subject will be blinded as to identity of the cream applied at each site.
Using a single blind approach, a thin film of either doxycycline 2% cream or control
emollient will be placed on entire test surface of either arm for an additional 30 min
then removed. Repeat skin and itch measurements will immediately be done.
4. After an additional 30 minutes after wiping off the cream repeat skin and itch
measurements will be done.
5. Reapplication - Investigators will then apply repeat film of cream to allergen test
surface sites only then send the subject home with instructions to not wash the sites
off for 6 hrs.
6. Repeat measurements at 24 hours post initial removal of cream.
