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

Asthma Clinical Trial

— GINA3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04202263
• Other study ID #: 1476585
• Status: Recruiting
• Phase: Phase 2
• Start date: September 26, 2019
• Est. completion date: September 25, 2023

Study information

• Verified date: October 2021
• Source: State University of New York - Downstate Medical Center
• Contact: Rauno O Joks
• Phone: 7182701569
• Email: rauno.joks[@]downstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Minocycline Topical
Placement of minocycline cream 0%, 1%, 2% or 3% at one of four identical allergen skin test sites.
• Placebos
Placement of minocycline cream 0%

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in itch scores by minocycline 1%, 2%, and 3% vs. placebo	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.	24 hours.