Recruiting
Phase 2

Minocycline

Sponsor:

State University of New York - Downstate Medical Center

Code:

NCT04202263

Conditions

Allergic Rhinitis

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Minocycline Topical

Placebos

Study Details

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.

Conditions

Allergic Rhinitis

Asthma

Study ID

NCT04202263

Start date

Sep 26, 2019

Status verified date

Oct, 2021

Completion date

Sep 25, 2023

Anticipated

Primary completion date

Sep 25, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo cream without minocycline

active comparator: Minocycline Arm

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

Interventions

Minocycline Topical

Placement of minocycline cream 0%, 1%, 2% or 3% at one of four identical allergen skin test sites.

Placebos

Placement of minocycline cream 0%

Primary outcome measure

  • Change in mean diameter of treatment induced effect on wheal size [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Locations

SUNY Downstate Medical Center

Recruiting

Brooklyn, New York, United States, 11203

Principal Investigator:

Rauno Joks, MD

More Information

Sponsor

State University of New York - Downstate Medical Center

Last update posted

Oct 14, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York - Downstate Medical Center on 2021-10-14.