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

State University of New York - Downstate Medical Center

Status and phase: Unknown; Phase 2

Conditions: Asthma; Allergic Rhinitis

Treatments: Drug: Placebos; Drug: Minocycline Topical

Study type: Interventional

Funder types: Other

Identifiers

NCT04202263

1476585

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo cream without minocycline

Treatment:

Drug: Placebos

Minocycline Arm

Active Comparator group

Description:

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

Treatment:

Drug: Minocycline Topical