Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline (GINA3)

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 Overview

• Status: Recruiting
• Conditions: Asthma; Allergic Rhinitis
• Intervention / Treatment: Drug: Placebos; Drug: Minocycline Topical

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rauno O Joks; Phone Number: 7182701569; Email: rauno.joks@downstate.edu
• Study Contact Backup: Name: Catherine Calacanis; Phone Number: 7182704715; Email: ccalacanis@aol.com

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • Recruiting
      • SUNY Downstate Medical Center
      • Principal Investigator: Rauno Joks, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: State University of New York - Downstate Medical Center
• Investigators: Principal Investigator: Rauno O Joks, State University of New York - Downstate Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2019
• Primary Completion (Anticipated): September 25, 2023
• Study Completion (Anticipated): September 25, 2023

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 13, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: 1476585

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No