Allergic Rhinitis, Asthma
Conditions
Brief summary
Adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). Each site will be challenged with up to three known allergens, saline and histamine controls. Mean wheal diameter after 20 minutes challenge will be determined. This is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. Measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours.
Detailed description
Adults with known respiratory allergy/asthma with known skin test sensitization will undergo repeat skin prick testing at 4 areas of both arms (bilateral forearms, bilateral upper arms). Each site will be challenged with up to three known allergens, saline and histamine controls. Mean wheal diameter after 20 minutes challenge will be determined. This is followed by placement of minocycline cream (0%, 1%, 2%, 3%), placed in randomized fashion at each of 1 of 4 skin test sites. Measurement of subsequent wheal diameter will be done at 30 minutes, 60 minutes and 24 hours. In addition, itch assessment at each site will be done at baseline, 30 minutes, 60 minutes and 24 hours using VAS and questionnaire.
Interventions
Placement of minocycline cream 0%, 1%, 2% or 3% at one of four identical allergen skin test sites.
DRUGPlacebos
Placement of minocycline cream 0%
Sponsors
State University of New York - Downstate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Each subject will simultaneously be tested for responses to placebo (0%), 1%, 2% and 3% minocycline cream responses to induced allergic skin inflammation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult ( ages 18-75) outpatients with diagnosis of allergic rhinoconjunctivitis and/or asthma who have previously undergone epicutaneous skin prick testing with detection of at least one allergen positive.
Exclusion criteria
* Subjects who are unable/unwilling to undergo cessation of oral antihistamines for five days prior to testing. * Current use of oral steroids or other systemic immunosuppressants, including omalizumab (anti-IgE therapy) and anti-IL-5 therapy. * Allergic asthmatics who have current uncontrolled asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean diameter of treatment induced effect on wheal size | 24 hours | Compare mean diameter of placebo associated mean wheal diameter vs. 1%, 2%, and 3% minocycline cream |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo | 24 hours. | Changes in both visual analogue scale (0 to 100mm, with greater itch being with higher scores) and verbal itch scores (0 to 3, with 0 being no itch and 3 being severe itch) with 1%, 2%,and 3% cream vs, placebo over time. |
Countries
United States
Contacts
Primary ContactRauno O Joks
Backup ContactCatherine Calacanis
Outcome results
None listed