search
Back to results

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

Primary Purpose

Allergic Rhinitis, Asthma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Minocycline Topical
Placebos
Sponsored by
State University of New York - Downstate Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SUNY Downstate Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Minocycline Arm

Arm Description

Placebo cream without minocycline

Minocycline cream (1%,2%,3%)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 4, 2019
Last Updated
October 13, 2021
Sponsor
State University of New York - Downstate Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04202263
Brief Title
Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
Acronym
GINA3
Official Title
Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
September 25, 2023 (Anticipated)
Study Completion Date
September 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Downstate Medical Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo cream without minocycline
Arm Title
Minocycline Arm
Arm Type
Active Comparator
Arm Description
Minocycline cream (1%,2%,3%)
Intervention Type
Drug
Intervention Name(s)
Minocycline Topical
Other Intervention Name(s)
minocycline
Intervention Description
Placement of minocycline cream 0%, 1%, 2% or 3% at one of four identical allergen skin test sites.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Minocycline 0%
Intervention Description
Placement of minocycline cream 0%
Primary Outcome Measure Information:
Title
Change in mean diameter of treatment induced effect on wheal size
Description
Compare mean diameter of placebo associated mean wheal diameter vs. 1%, 2%, and 3% minocycline cream
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rauno O Joks
Phone
7182701569
Email
rauno.joks@downstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Calacanis
Phone
7182704715
Email
ccalacanis@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rauno O Joks
Organizational Affiliation
State University of New York - Downstate Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rauno Joks, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs