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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 25, 2023

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

  • Drug: Minocycline Topical
    • Placement of minocycline cream 0%, 1%, 2% or 3% at one of four identical allergen skin test sites.
  • Drug: Placebos
    • Placement of minocycline cream 0%

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Placebo cream without minocycline
  • Active Comparator: Minocycline Arm
    • Minocycline cream (1%,2%,3%)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • State University of New York – Downstate Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rauno Joks, MD, Chief Division of Allergy Immunology – State University of New York – Downstate Medical Center
  • Overall Official(s)
    • Rauno O Joks, Principal Investigator, State University of New York – Downstate Medical Center
  • Overall Contact(s)
    • Rauno O Joks, 7182701569, rauno.joks@downstate.edu

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