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

NCT ID: NCT04202263

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2023-09-25

Brief Summary

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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

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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.

Conditions

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Allergic Rhinitis Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Placebo cream without minocycline

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Placement of minocycline cream 0%

Minocycline Arm

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

Group Type ACTIVE_COMPARATOR

Minocycline Topical

Intervention Type DRUG

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

Interventions

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Minocycline Topical

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

Intervention Type DRUG

Placebos

Placement of minocycline cream 0%

Intervention Type DRUG

Other Intervention Names

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minocycline Minocycline 0%

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York - Downstate Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Rauno Joks, MD

Chief Division of Allergy Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rauno O Joks

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Downstate Medical Center

Locations

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SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rauno O Joks

Role: CONTACT

[email protected]
7182701569

Catherine Calacanis

Role: CONTACT

[email protected]
7182704715

Other Identifiers

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1476585

Identifier Type: -

Identifier Source: org_study_id