Clinical trial NCT04202263: Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
Official title: Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Allergic Rhinitis
Asthma
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in mean diameter of treatment induced effect on wheal size
timeFrame: 24 hours
Secondary outcomes:
measure: Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo
timeFrame: 24 hours.
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
affiliation: State University of New York - Downstate Medical Center
name: Rauno O Joks
role: PRINCIPAL_INVESTIGATOR
References: