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

Phase 2

• Conditions: Allergic Rhinitis; Asthma
• Interventions: Drug: Minocycline Topical; Drug: Placebos

• Registration Number: NCT04202263
• Lead Sponsor: State University of New York - Downstate Medical Center

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.

Study Timeline

• Study Start: 2019-09-26
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-17
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14
• Primary Completion: 2023-09-25
• Study Completion: 2023-09-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minocycline Arm	Minocycline Topical	Minocycline cream (1%,2%,3%)
Placebo	Placebos	Placebo cream without minocycline

Primary Outcome Measures

Name	Time	Method
Change in mean diameter of treatment induced effect on wheal size	24 hours	Compare mean diameter of placebo associated mean wheal diameter vs. 1%, 2%, and 3% minocycline cream

Secondary Outcome Measures

Name	Time	Method
Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo	24 hours.	Changes in both visual analogue scale (0 to 100mm, with greater itch being with higher scores) and verbal itch scores (0 to 3, with 0 being no itch and 3 being severe itch) with 1%, 2%,and 3% cream vs, placebo over time.

Trial Locations

Locations (1)

SUNY Downstate Medical Center; 🇺🇸 Brooklyn, New York, United States