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

NCT04202263 | Unknown Phase 2 FDA Drug

• 1 other identifier: 1476585
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  24 hours.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo cream without minocycline

Drug: Placebos

Minocycline Arm

ACTIVE COMPARATOR

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

Drug: Minocycline Topical

Interventions

Minocycline Topical DRUG

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

Also known as: minocycline

Minocycline Arm

Placebos DRUG

Placement of minocycline cream 0%

Also known as: Minocycline 0%

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic; Asthma

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Rauno O Joks

  State University of New York - Downstate Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rauno O Joks

CONTACT

7182701569; rauno.joks@downstate.edu

Catherine Calacanis

CONTACT

7182704715; ccalacanis@aol.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Division of Allergy Immunology

Model Details: Each subject will simultaneously be tested for responses to placebo (0%), 1%, 2% and 3% minocycline cream responses to induced allergic skin inflammation.

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: December 17, 2019
• Study Start: September 26, 2019
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)