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

Phase 2UnknownNCT04202263

State University of New York - Downstate Medical Center25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Allergic Rhinitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 24 hours

Secondary Outcomes

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.

Time frame: 24 hours.