Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline

Conditions
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Allergic Rhinitis, Asthma

Intervention / Treatment
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* Drug: Minocycline Topical
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo cream without minocycline | Drug: Placebos<br>* Placement of minocycline cream 0%<br>* Other names: Minocycline 0%;|
| Active Comparator: Minocycline Arm<br>Minocycline cream (1%,2%,3%) | Drug: Minocycline Topical<br>* Placement of minocycline cream 0%, 1%, 2% or 3% at one of four identical allergen skin test sites.<br>* Other names: minocycline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean diameter of treatment induced effect on wheal size | Compare mean diameter of placebo associated mean wheal diameter vs. 1%, 2%, and 3% minocycline cream | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo | 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. | 24 hours. |